Below you will find a listing of all upcoming BioWorld and Medical Device Daily audio conferences.

One fee allows you to invite as many listeners from your facility as you can accommodate around your conference telephone. Plus, you and your staff will benefit from the interactive question-and-answer segment immediately following the presenter's prepared remarks.

Upcoming Audio Conferences:

Clinical Trial SOPs: Ensure Your Procedures are Compliant and Followed Correctly

When: Thursday, September 9, 2010
What Time: 2:00pm – 3:30pm ET
Where: Your office or conference room
Cost: Just $325 per listening site no matter how many people are in the room!

Best Value! Audio Conference PLUS Audio CD and Transcript: $479 —— Order Now!

Clinical regulations are open to interpretation. When you or your research staff have questions about how, in practice, to ensure compliance, your company's SOPs should have the answer.

But do they? And when the FDA investigator reviews them, will she agree? In this 90 minute audio conference, former FDA investigator Bernadette Ott will provide strategies on writing, reviewing, and enforcing clinical SOPs, for both compliance and usability.

Click here for more information on the audio conference; or click here to order online or call 1-800-688-2421 (1-404-262-5474) to order the CD recording (MP3 format). Please mention priority code T10631-12119.

A Drug Recall Case Study: Lessons Learned from a Widespread Drug Recall at a Major Pharmaceutical Company

When: Tuesday, September 14, 2010
What Time: 2:00pm – 3:30pm ET
Where: Your office or conference room
Cost: Just $325 per listening site no matter how many people are in the room!

Best Value! Audio Conference PLUS Audio CD and Transcript: $479 —— Order Now!

A drug recall can make or break your brand. If handled properly, a drug recall can instill trust in your customers, protect your brand name, and mitigate your legal risk. An improperly handled drug recall, however, can result in a loss of brand confidence, decreased sales, and negative attention from the FDA and other health agencies.

With an enforcement-focused FDA, it's even more important to take a proactive approach to drug recalls. In this 90-minute audio conference, industry expert Barton Cobert will share his experience of a widespread drug recall at a major global pharma company. He will also provide best practice strategies for planning and implementing effective drug recalls.

Click here for more information on the audio conference; or click here to order online or call 1-800-688-2421 (1-404-262-5474) to order the CD recording (MP3 format). Please mention priority code T10632-12139.

False Claims Act Liability for Pharmaceutical and Medical Device Companies: How Will Recent Changes Affect You?

When: Tuesday, September 21, 2010
What Time: 2:00pm – 3:30pm ET
Where: Your office or conference room
Cost: Just $325 per listening site no matter how many people are in the room!

Best Value! Audio Conference PLUS Audio CD and Transcript: $479 —— Order Now!

For nearly a decade, pharmaceutical and medical device companies have been under assault by the federal government and the private whistleblower bar using the False Claims Act (FCA) as a primary weapon. Amendments to the FCA in 2009, and again in 2010, create ambiguities in the legal landscape, particularly for defendants. As courts interpret these amendments, it is essential that pharmaceutical and medical device companies stay abreast of the developing FCA.

In this 90-minute audio conference, attorneys Patrick O'Brien and William Gould will explain the evolution of the FCA and what you can expect for the future of FCA liability.

Click here for more information on the audio conference; or click here to order online or call 1-800-688-2421 (1-404-262-5474) to order the CD recording (MP3 format). Please mention priority code T10633-12164.

How Health Care Reform and Other New Legislation Will Affect the Regulation of Advertising and Promotion

When: Tuesday, September 28, 2010
What Time: 2:00pm – 3:30pm ET
Where: Your office or conference room
Cost: Just $325 per listening site no matter how many people are in the room!

Best Value! Audio Conference PLUS Audio CD and Transcript: $479 —— Order Now!

The Patient Protection and Affordable Care Act ("PPAC") will significantly affect the pharmaceutical industry, but relatively little attention has been paid to the profound effects that PPAC and other new laws will have on the advertising and promotion of pharmaceuticals to health care professionals and consumers. These new laws will play a prominent role in defining the pharmaceutical industry's ability to commercialize its products and to remain in compliance with FDA regulations and stay out of trouble with the Office of Inspector General of HHS.

In this 90-minute audio conference, industry experts Wayne Pines and Howard Dorfman will discuss the impact on pharmaceutical advertising and promotion from the latest legislative initiatives.

Click here for more information on the audio conference; or click here to order online or call 1-800-688-2421 (1-404-262-5474) to order the CD recording (MP3 format). Please mention priority code T10634-12184.

FDA's Changes to the 510(k) Process: Are You Prepared?

When: Thursday, September 30, 2010
What Time: 2:00pm – 3:30pm ET
Where: Your office or conference room
Cost: Just $325 per listening site no matter how many people are in the room!

Best Value! Audio Conference PLUS Audio CD and Transcript: $479 —— Order Now!

The FDA is revamping its 510(k) approval process for medical devices. With the FDA's recently released recommendations on how to improve the 510(k) process, it appears that the 510(k) process will soon see many changes.

With expected changes in the usage of 510(k) definitions and, more broadly, in the operation of the program, it is essential that those in the medical device industry begin to prepare now to ensure future compliance.

In this 90-minute audio conference, attorneys James Ravitz and Naomi Halpern of Arent Fox LLP will explain what you need to know about the FDA's recommendations for the 510(k) process. Mr. Ravitz and Ms. Halpern will also describe what steps you can take to begin planning for the upcoming changes.

Click here for more information on the audio conference; or click here to order online or call 1-800-688-2421 (1-404-262-5474) to order the CD recording (MP3 format). Please mention priority code T10635-12202.

Device Complaint Handling: Implications for CAPA, Reporting, Recalls, and More

When: Tuesday, October 5, 2010
What Time: 2:00pm – 3:30pm ET
Where: Your office or conference room
Cost: Just $325 per listening site no matter how many people are in the room!

Best Value! Audio Conference PLUS Audio CD and Transcript: $479 —— Order Now!

Over half the Warning Letters issued for quality system violations in the past six months have included issues related to complaint handling and CAPA. The FDA has increased its focus on enforcement, and compliance with 820.198 of the Quality System Regulation will be scrutinized now more than ever.

In this 90 minute audio conference, medical device expert Judith Andrews, Ph.D. will address the essential elements for maintaining an effective and compliant complaint handling system. Additionally, she will explain what you need to know about CAPA, reporting, and recalls when handling complaints.

Click here for more information on the audio conference; or click here to order online or call 1-800-688-2421 (1-404-262-5474) to order the CD recording (MP3 format). Please mention priority code T10636-12257.

Past Audio Conferences Available on CD:

The fee of just $325 per CD allows you to share this valuable information with as many listeners from your facility as you wish. Just click the title of the audio conference below that you wish to purchase on CD.

Overcoming Biotech Intellectual Property Rights Issues in China and India

The importance of understanding intellectual property rights when doing business overseas cannot be overstated. Reports say that some progress is being made in terms of intellectual property rights protection when dealing with China and India, two emerging biotech giants. But how safe is it to do business there? What do biotech executives need to know before doing business in China and India, or partnering with companies there?

In this 90-minute interactive audio conference CD, you'll learn the answers to these questions and get an understanding of some of the major mistakes to avoid, what are potential sticky points when it comes to intellectual property rights, and what is the best approach to making a successful entry with biotechs.

Click here for more information on the audio conference; or click here to order the cd online or call 1-800-688-2421 (1-404-262-5474) to order the CD recording (MP3 format). Please mention priority code 11T08486 - EM5139.

The FDA's 505(b)(2) Drug Approval Process: How to Navigate the Pathway

Pipeline-strapped biotechnology and pharmaceutical companies increasingly are using the FDA's 505(b)(2) approval pathway, which lets companies modify and reposition existing drugs for quicker marketing clearance. But there's also the 505(b)(1) for new molecular entities and 505j, the abbreviated new drug application. Understanding the distinctions and choosing the right submission pathway to take can mean the difference between success and failure of your new drug's approval.

In this 90-minute interactive audio conference CD, you'll discover that the 505(b)(2) process is more intricate than simply generic vs. modified through a changed molecule or delivery route. You also will learn how to navigate and use the distinctions to save your company time and money.

Click here for more information about the audio conference; or click here to order the cd online or call 1-800-688-2421 (1-404-262-5474)to order the CD recording (MP3 format). Please mention priority code 11T08485 - EM5138.

Avoiding a Device Recall: Customer Feedback and the FDA's Postmarket Transformation Initiative

It is a given that med-tech companies must have systems in place to receive, investigate, analyze, and act on complaints and other information from users, patients, and professionals. But recently the FDA's Center for Devices and Radiological Health (CDRH) has initiated specific action plans to increase and improve the available information on device postmarket issues. The FDA is no longer waiting until an inspection to discover potential problems with marketed devices. This means that medical device companies must increase their vigilance in gathering, analyzing and addressing problems with their devices in distribution or they could face immediate and potentially costly product recalls.

Click here for more information on the audio conference; or click here to order the cd online or call 1-800-688-2421 (1-404-262-5474) to order the CD recording (MP3 format). Please mention priority code 11T07481-EM5134.

The new FDA Amendments Act contains two important provisions impacting direct-to-consumer advertising of prescription drugs: 1) a voluntary user fee program for companies seeking advisory reviews for their prescription drug DTC television advertisements; and 2) civil money penalties for any DTC advertisement deemed false or misleading.

Click here for more information about the audio conference; or click here to order the cd online ; or call 1-800-688-2421 (1-404-262-5474) to order the CD recording (MP3 format). Please mention priority code 11T07484-EM5137.

Off-Label Promotion: Be Careful, Be Very Careful

The U.S. DoJ is investigating more than 150 drug and medical device companies for alleged off-label promotion. Last year, Pfizer paid nearly $35 million to settle off-label marketing claims of its growth hormone Genotropin, joining the ranks of companies large (Eli Lilly) and small (Intermune) to recently settle with the DoJ over alleged off-label promotion. Less than two years ago, Schering Sales, a subsidiary of Schering-Plough, agreed to pay $435 million in criminal and civil fines in pleading guilty to a single count of off-label promotion. But this pales in comparison to Eli Lilly, which is reportedly considering a $1 billion dollar payout to federal and state investigators over alleged off-label promotion of Zyprexa.

This 90-minute interactive audio conference CD will examine the many laws that apply to off-label promotion, describe the risks to consider when interacting with healthcare professionals, and will provide strategies to develop an effective compliance program.

Click here for more information on the audio conference; or click here to order the CD online or call 1-800-688-2421 (1-404-262-5474) to order the CD recording (MP3 format). Please mention priority code 11T08487 - EM5140.

Avoid FDA Warning Letters With Strong CAPA Program

53 warning letters have been issued over the last 12 months by the FDA to medical device companies for inadequate corrective and preventive action (CAPA) procedures. These warnings have gone to the largest companies (e.g., Medtronic, Abbott, GE) as well as some of the smallest.

This 90-minute audio conference CD will help companies develop and implement a compliant and effective CAPA system. It will help attendees analyze processes and work operations, guide them on making concessions and setting priorities on resources. Finally, it will show them an 8-step workflow for executing the CAPA process from start to finish, and provide insight and strategies for success at each step. It will also show what to do if the CAPA process fails to prevent or correct a given action.

Click here for more information on the audio conference; or click here to order the CD online or call 1-800-688-2421 (1-404-262-5474) to order the CD recording (MP3 format). Please mention priority code 11T08488 - EM5141.

Biofuels continue to be an attractive and cutting-edge area of technology for research and investment. Yet, there are a myriad of technologies, both potential and implausible, that are being promoted daily. This 90-minute interactive audio conference CD will help you gain an understanding of the latest technologies, what is working and what is not, and what regulatory and market developments will shape this industry.

Click here for more information on the audio conference; or click here to order the CD online or call 1-800-688-2421 (1-404-262-5474) to order the CD recording (MP3 format). Please mention priority code 11T08489 - EM5142.

Biosimilars in the U.S.: What the Approval Process Could Look Like, and What We've Learned From the EU

After numerous false starts, the United States Congress, President, and FDA are collaborating on a pathway for biosimilars. Sometimes called biogenerics, or follow-on biologics, what to call the unbranded version of a large molecule medicine is far from the only source of confusion.

Since April 2006, when the first biosimilar was approved for sale in the EU, questions have been raised, ranging from the fundamental (access by the generics company to the biologic's formula) to the secondary (market competition). Biosimilars in the United States will face even more questions. Since the payer and reimbursement system in the U.S. is different than in many European countries, getting biosimilars into the hands of patients could be even more challenging. This coupled with uncertain Congressional plans for innovator exclusivity and data required for approval leaves branded and generics companies with more questions than answers.

This 90-minute audio conference CD will provide insight and understanding from Linda Horton, an FDA veteran and expert on EMEA policy. It will examine the EU biosimilars pathway, and the lessons that have been learned over the last two years. It will describe the U.S. legislation at present, what changes are likely, and provide an estimated timeline for major milestones along the way.

Click here for more information on the audio conference; or click here to order the CD online or call 1-800-688-2421 (1-404-262-5474) to order the CD recording (MP3 format). Please mention priority code 11T08490.

Auditing Suppliers and Contractors: Be Ready for Increased FDA Scrutiny

FDA regulations are clear—whether for drugs or devices, you are responsible for the quality of your product, regardless of what areas of your operation you outsource, or who actually makes your product.

That's why the company of record for Heparin could be facing trouble, after four deaths and hundreds of illnesses were potentially linked to its drug. The actual production of the compound had been contracted to a company which in turn subcontracted the work to a Chinese manufacturer.

To avoid warning letters, recalls, seizures, lawsuits and more, attend this 90-minute audio conference. You'll learn how to be sure your outsourced suppliers will follow FDA regulations. You'll learn what the FDA is looking for, and how things may change with the many recent supply chain safety failures.

Click here for more information on the audio conference; or click here to order the CD online or call 1-800-688-2421 (1-404-262-5474) to order the CD recording (MP3 format). Please mention priority code T08491 - EM5144.

INDs in eCTD Format: Your Roadmap for Electronic FDA Submission Requirements

You now have two choices when submitting an investigational new drug application (IND) to the FDA:

1. Submit hundreds of printed pages to CDER. Hope that it gets delivered on time, no pages get lost anywhere along the way, and that no one spills coffee on it. As for revisions, well, there's always Wite-Out.



2. Submit electronically in eCTD format.

For companies doing business in the 21st century, option #2 is the only one that makes sense–especially since, should you decide that you want to submit your NDA electronically, you won't have to convert from your old, likely incompatible format. You also reduce the chances of "refuse to file" decisions down the line, or of incorrectly transferring data from one source to another. It's easier to make changes, as well.

But there are also challenges to filing an IND in eCTD format. You must have a comprehensive plan, since IND submissions span a longer timeframe. Data may be presented later in ways that were not anticipated at the start. Preclinical data presentation also presents a challenge.

This 90-minute audio conference will provide strategies to deal with these challenges, and help you make a 21st century submission to the FDA.

Click here for more information on the audio conference; or click here to order the CD online or call 1-800-688-2421 (1-404-262-5474) to order the CD recording (MP3 format). Please mention priority code T08492 - EM5145.

Medical Device Recalls: Strategies and Best Practices to Know Before a Recall Order is Issued

Despite the best efforts by R&D, quality control, auditors, and the rest of your medical device team, recalls still occur. In fact, more device recalls were issued in 2005 than in any of the previous 10 years. And while 2006 saw a small overall decline, Class I recalls (the most serious kind) were more than double what they were just two years before, a trend that has continued through last year and on into 2008.

Plus, with ICD and pacemaker recalls getting significant media attention, continuing controversy over the safety of stents, and growing concern over the safety of products made overseas, medical device companies must be prepared for recalls at a moment's notice.

This 90-minute audio conference will provide not only the best practices for recalls, but will show how they should be integrated into a recall preparation strategy. Make sure that you have the people and procedures in place now, so you can hit the ground running when the recall notice is issued.

Click here for more information on the audio conference; or click here to order the CD online or call 1-800-688-2421 (1-404-262-5474) to order the CD recording (MP3 format). Please mention priority code T08493 - EM5146.

Solving the Challenges of Adaptive Clinical Trials

Promising medicines fail - this is the reality of drug development. But when these meds fail in Phase III (as 50% of all failed drugs do), years of work are lost. And with the pharma product development pipeline having slowed to a trickle, precious resources must be allocated to winners.

Adaptive trial design promises to help do exactly that. Deploying an adaptive trial, however, must be done differently than the standard model for both success and FDA compliance.

This audio conference CD will show the benefits and opportunities for adaptive designs to improve clinical development planning, as well as describe the challenges and pitfalls to implementation.

Click here for more information on the audio conference CD; or click here to order the CD online or call 1-800-688-2421 (1-404-262-5474) to order the CD recording (MP3 format). Please mention priority code 11T08494.

Dos and Don'ts for Designing Patient Registries

The approval of a drug or device is not the final step. This has been made clear through the increased expectation of post-market research by the Food and Drug Administration Amendments Act (FDAAA). Patient registries can produce real-world data which accurately depicts the safety, quality, performance and effectiveness of biotech and med-tech products.

In a new BioWorld Today and Medical Device Daily audio conference CD, speaker Richard Gliklich, MD, president and CEO of Outcome Sciences Inc., will present effective innovations in patient registry design as well as how to maximize registries for multiple purposes, and how registries offer support for overall company and compliance needs.

Dos and Don'ts for Designing Patient Registries For more information or to register, call 800-688-2421 or 404-262-5474. Please mention priority code 11T08495.

REMS Required 3 Months From Now Are You Ready?

A little-noticed provision of 2007's FDAAA could present tremendous compliance problems for drug companies the Risk Evaluation and Mitigation Strategies provisions, or REMS.

In the first wave of requirements, the makers of 16 products on the market will have until September 21 to submit their REMS for FDA approval.

Further, for drugs that do not currently have a REMS imposed on them, the FDA will review adverse events databases every two weeks to look for new safety signals and serious adverse events. If they find them, the agency can demand a REMS be put in place. As such, every drug is at risk.

Of course, the FDA can impose a REMS on any new drug as a condition for approval.

So what, practically, is a REMS? Is it like a RiskMAP? Will the FDA require all the options for a REMS as defined in FDAAA? What can the agency do if a REMS is not executed to its satisfaction?

In this 90-minute audio conference CD, Dr. Edgar Adams will describe exactly what a REMS is, and what it is not. For those familiar with RiskMAPs, he'll demonstrate how REMS are similar, and how they differ. Most importantly, he'll show companies how to plan their required REMS submissions, and how to prepare for increased FDA scrutiny for drugs not currently governed by safety restrictions.

Click here for more information on the audio conference CD; or click here to order the CD online or call 1-800-688-2421 (1-404-262-5474) to order the CD recording (MP3 format). Please mention priority code T08496.

Building and Maintaining BioPharma Patent Portfolios After KSR v. Teleflex: Strategies Addressing Higher Standards for Patentability

One year after KSR v. Teleflex, the Supreme Court decision that raised the bar for getting and maintaining patents, questions remain for drug, biotech, and medical device companies. What is clear is that companies, whether they have one patent or 1,000, must be on guard to protect their intellectual property.

This 90-minute interactive audio conference CD will give you tools and techniques to deal with the effects of the KSR v. Teleflex decision in the context of patent portfolio management and development. Our conference will also address what kinds of inventions are most vulnerable to failure in the patent prosecution process and how to maximize chances for overcoming rejections and validity attacks based on asserted obviousness of the invention.

This audio conference CD will show the benefits and opportunities for adaptive designs to improve clinical development planning, as well as describe the challenges and pitfalls to implementation.

Click here for more information on the audio conference CD; or click here to order online or call 1-800-688-2421 (1-404-262-5474) to order the CD recording (MP3 format). Please mention priority code 11T08497.

Quality System Audits: Lessons Learned in Medical Device Risk Management

28 medical device companies in the last 12 months have received warning letters for non-compliant quality system internal audits. Violations range from a complete lack of auditing procedures to insufficient audit frequency, failure to re-audit, and simple documentation oversights.

Internal QS audits are important, not only for basic compliance, but for risk management and ensuring the health of the quality system. Problems can be found and fixed that otherwise could lead to defects, product recalls, and liability suits. Inefficiencies can be discovered, creating opportunities to reduce costs and waste.

In this 90-minute audio conference CD, QS expert Susan Reilly will show how to best perform this essential detective work. She'll describe how to organize and coordinate internal audits, from initial planning to team selection, to execution and documentation, and through analysis and planning for the next audit.

Click here for more information on the audio conference; or click here to order the CD online or call 1-800-688-2421 (1-404-262-5474) to order the CD recording (MP3 format). Please mention priority code 11T08498.

Clinical Trial Recruitment Methods and Metrics to Meet Last Patient In Goals

Every research site and CRO tells you the same thing: they promise excellence, assure compliance, and claim they have the best subject recruitment and retention methods available.

But how do you know that? How can you be sure that the sites you ve selected will meet your Last Patient In targets? You need more than promises—you need the proper analytics and methods to determine realistic enrollment goals, and to apply them to your research partners.

In this 90-minute audio conference CD, Joshua Schultz, Vice President of Clinical Research Services for PAREXEL International, will describe the technology, data assets, and process changes you need to better predict and manage recruitment and retention. He will help you establish the appropriate data assets to determine trial staffing, budget, and timelines and advance subject recruitment. He will also provide case studies that demonstrate successful use of these tools to improve recruitment.

Click here for more information on the audio conference; or click here to order the CD online or call 1-800-688-2421 (1-404-262-5474) to order the CD recording (MP3 format). Please mention priority code T08499.

CME and Off-Label Promotion: Find and Fix Noncompliance Before the Feds Do

The line between legitimate continuing medical education (CME) and illegal off-label promotion of a drug or device can be a fine one. Sales and marketing staff, often with proper intentions, can place their companies on the wrong side of the law. And the DOJ, FDA, HHS and others will come after compliance officers and executives who may have no knowledge of such misconduct.

Just ask Michael Friedman, Howard Udell and Paul Goldenheim. They were CEO, general counsel, and chief scientific officer, respectively, at Purdue Pharma, when off-label promotion, in part through CME, was allegedly used to push OxyContin. They personally paid more than $34 million to the government, despite Purdue s statement that the three executives "neither engaged in nor tolerated the misconduct at issue in this investigation."

Be prepared. In this 90-minute audio conference CD, former federal prosecutor Joseph Burby and attorney Elizabeth Gobeil will detail the rules of CME and promotion. Through case studies, they ll examine what constitutes legitimate education, and provide the red flags that investigators are looking for. They ll also describe recent enforcement activities with an eye toward governmental priorities for the future.

Click here for more information on the audio conference; or click here to order the CD online or call 1-800-688-2421 (1-404-262-5474) to order the CD recording (MP3 format). Please mention priority code 11T08500.

Negotiating Clinical Trial Agreements: Strategies to Protect Your Business Interests

Perhaps your company has been outsourcing trials for decades. Or maybe you are just starting. Either way, you know this is one of the most important and most challenging aspects of the business. Get the wrong contract in place or even have a single unfriendly provision in the agreement, and you could be unable to protect your IP, be unable to access to your trial data, or take on some of the trial site's risk in subject injury lawsuits.

To protect your company, listen to this fast-paced, information-packed audio conference CD with attorney Katherine Leibowitz. She'll examine the biggest business issues in contracting with sites and provide real-world solutions on how to deal with them. She'll provide realistic, practical guidance to help you create terms sites will accept, but will protect your interests.

Click here for more information on the audio conference; or click here to order the CD online or call 1-800-688-2421 (1-404-262-5474) to order the CD recording (MP3 format). Please mention priority code 11T08501.

FMEA: Risk Management and Prioritization in Medical Device Design

In medical device design, you cannot stop risk you can only hope to manage it. A small mistake in risk prioritization in the design lab can cost a company millions of dollars and hundreds of jobs, should a recall or lawsuit follow.

Two essential elements of risk management of medical devices are recognizing the possible failures, and communicating this failure risk to the designers and developers of the device.

In this 90-minute audio conference CD, engineering experts Marta Villarraga, Ph.D., and Yakov Shkolnikov, Ph.D., will present one technique for identifying and prioritizing failures Failure Mode and Effects Analysis (FMEA). Implementing this method into a device s design process increases the chances of producing an end product that is safe and effective for its intended use.

To solidify the understandings of the principles of the failure modes and effects analysis, participants will complete a mock FMEA for a hypothetical electrically active eye prosthesis. Analysis of failure modes of this example will illustrate how, even in a device with very diverse functional blocks, FMEA is an effective tool for ranking risk.

Click here for more information on the audio conference; or click here to order the CD online or call 1-800-688-2421 (1-404-262-5474) to order the CD recording (MP3 format). Please mention priority code 11T08502.

Foreign Corrupt Practices Act: The DoJ and SEC Are Coming—Are You Ready?

What are you doing to prevent violations of the Foreign Corrupt Practices Act (FCPA)?

2007 saw 38 FCPA enforcement actions by the DoJ and SEC—more than the prior four years combined! Among those caught in the crosshairs of a Federal FCPA investigation were Medtronic, Stryker, Biomet, Smith & Nephew, Zimmer, and Johnson & Johnson.

And according to the DoJ, 2007 was "just the tip of the iceberg," with "many more matters under investigation." Likewise, the SEC is, according to an official, engaging in "a full-court press on FCPA investigations."

Pharmaceutical and medical device companies face special challenges in complying with the FCPA. In many countries, doctors and hospital staff are on the government payroll—as such, they can be considered "foreign officials," making payments to them potentially illegal. Even making contributions to an official's favored charity can run afoul of the FCPA, as Schering Plough found out in 2004.

So how do you secure your compliance program against FCPA violations? In this 90-minute audio conference, Pfizer's Assistant General Counsel and Deputy Compliance Officer Gary Giampetruzzi will provide insider insight on what kind of compliance program the U.S. government wants to see, and how to put into place the controls needed for FCPA compliance.

Click here for more information on the audio conference; or click here to order the CD online or call 1-800-688-2421 (1-404-262-5474) to order the CD recording (MP3 format). Please mention priority code 11T08503.

FDA Preemption: What's Happening and What Does It Mean for Me?

Whether and how FDA preemption of state product liability actions is accepted by the courts could forever change how drugs and medical devices are marketed in the United States. From clinical trials and product submissions to manufacturing and labeling, everyone involved in the product chain will be affected.

The issue remains undecided as the Supreme Court is poised to rule on the Wyeth v. Levine prescription-drug-labeling case next year. Prognosticators are already trying to predict the outcome of Levine based on the court's recent ruling in favor of preemption in the Riegel v. Medtronic medical-device case. Meanwhile, Congress is considering calls to block preemption, and has held hearings to hear the views of members of the public, academia, FDA, state officials, and a respected medical journal.

In this 90-minute audio conference CD, Linda Pissott Reig and John T. Chester, attorneys who represent drug, medical device, and biologic companies in regulatory and litigation matters, will examine the current and future preemption landscape. They'll describe the significance of FDA's preemption position and recent court rulings, discuss what is (and may be) coming next, and present practical strategies that FDA-regulated drug and medical device companies can follow while preemption is in flux.

NOTE: Linda and John will present a second audio conference following the Wyeth v. Levine decision - attendees of this audio conference will receive a special discount when they sign up for the second presentation.

Click here for more information on the audio conference; or click here to order online or call 1-800-688-2421 (1-404-262-5474) to order the CD recording (MP3 format). Please mention priority code 11T08504.

FDA Inspections in China: Your Manufacturing Operations Are in the Crosshairs—Be Ready

Even before the Heparin debacle discovered in March that left as many as 90 people dead, the FDA was working to place inspectors on the ground in China. Now that full-time staff is in place, and with a permanent office scheduled to open in October, what will the impact be on your operations there?

Can you expect the agency to inspect with even higher scrutiny, in the hopes of "making example" of someone? Will they look for different violations than they do in the U.S.? What if your outsourced supplier is in violation—will you take the hit?

Just as important, are you ready to host an inspection, even if it is unannounced? Are your manufacturing facilities in compliance? Are your training records in order and available for review? What about your SOPs? Will your staff even be able to communicate with inspectors?

In this 90-minute audio conference CD, health and China law expert Joan McEntee will provide strategic guidance on the changing face of FDA-regulated manufacturing in China.

Click here for more information on the audio conference; or click here to order online or call 1-800-688-2421 (1-404-262-5474) to order the CD recording (MP3 format). Please mention priority code 11T08505.

Medical Device Complaint Handling: Solving Your Toughest Reporting Problems

FDA investigators consider how a medical device company handles complaints to be a harbinger—if the MDR system is out of a "state of control," chances are the rest of the quality system is, too. 48 companies over the last 12 months have received warning letters for non-compliant complaint handling.

Handling complaints correctly is a huge challenge. This 90-minute audio conference CD will help companies solve the most common, and most difficult, MDR issues.

Click here for more information on the audio conference; or click here to order online or call 1-800-688-2421 (1-404-262-5474) to order the CD recording (MP3 format). Please mention priority code 11T08506.

Off-Label and Journal Articles: The Reprints May Be Black and White, but Compliance Is Not

Off-label dissemination via scientific and journal articles is one of the most challenging areas of marketing compliance.

The FDA has issued a draft guidance on Good Reprint Practices. During the public comment period, many comments were submitted to the agency. Some spoke in favor of the guidelines, noting doctors should be informed of safe and effective uses for approved drugs, even if not FDA-approved for a particular condition. Others, including some government officials, indicated that the ability to prosecute off-label promotion cases would be negatively affected by this perceived "loophole."

Also during this comment period, the Journal of the American Medical Association reported that a major drug company ghostwrote numerous scientific journal articles in support of off-label uses for one of its blockbuster drugs. The drug was later pulled from the market due to safety concerns.

So how do you ensure your sales, marketing, and medical affairs professionals are complying with the law and best industry practices? In this 90-minute audio conference CD, expert regulatory attorney Alan Minsk , Partner and Chair of the Food and Drug Practice Group at Arnall Golden Gregory LLP, will examine this specific area of sales and marketing compliance, and help companies evaluate the issues to consider when making decisions in the murky area of journal reprint distribution.

Click here for more information on the audio conference; or click here to order online or call 1-800-688-2421 (1-404-262-5474) to order the CD recording (MP3 format). Please mention priority code 11T08507.

C-51: The Biggest Changes Ever to Canada's Food and Drugs Act

Important changes to Canada's food and drugs laws have been introduced in the Canadian House of Commons by the Canadian federal government to modernize and strengthen Canada's safety system for food and health products (Bill C-51, An Act Respecting Foods, Therapeutic Products and Cosmetics).

Bill C-51 essentially overhauls the existing Canadian Food and Drugs Act by restructuring its format and introducing new definitions (e.g., therapeutic products), expanding regulatory authority and making provision for new regulation-making powers. All participants in the Canadian food and drug environment will be affected by this new regulatory framework.

How can you deal with these profound changes to the Canadian market? Jeffrey Graham, Andrew Loh and Tim Buckley, partners in the national biotech and pharmaceutical practice of Borden Ladner Gervais, Canada's largest law firm, will provide a practical overview of Bill C-51. They will describe what it will change, what remains unclear, and what it all means for you.

Click here for more information on the audio conference; or click here to order online or call 1-800-688-2421 (1-404-262-5474) to order the CD recording (MP3 format). Please mention priority code 11T08508.

Clinical Trial Agreements: Insight for Sites

Clinical investigators are faced with the daunting task of negotiating clinical trial agreements with huge drug and medical device firms. Even small drug companies have far more attorneys at their disposal than most sites. At the same time, the wrong language in a CTA can have a devastating financial impact on a site, be it commercial or academic.

But there is help. Let clinical trials expert Terry Stubbs guide you in developing CTA language that benefits you, and that will be acceptable to sponsors. She'll pinpoint the areas of greatest contention, and share what to fight for, and what it is safe to concede. She'll also describe how to effectively counter-offer terms offered by sponsors that are unfavorable to you.

Click here for more information on the audio conference; or click here to order the cd online or call 1-800-688-2421 (1-404-262-5474) to order the CD recording (MP3 format). Please mention priority code 11T08509.

Trial Master File: Ensure Your Trial Documentation Will Pass FDA Inspection

Your clinical trial has zero chance of passing an FDA inspection or QA audit if your Trial Master File (TMF) is not in order.

The FDA frequently states that if compliance isn't documented, it didn't happen. Your TMF serves as living proof that you are adhering to GCP, and that your quality system is in a state of control.

Beyond simply being a get out of jail free card, a well-maintained TMF can make trial management easier; with a typical TMF containing thousands of pages of documentation, you could easily save, or lose, hundreds of hours over the life of a trial searching for individual pieces of knowledge.

In this 90-minute audio conference CD, clinical trials expert Carl Anderson will provide guidance on the TMF. He'll describe the steps to take throughout a trial to ensure your TMF will pass inspection by FDA investigators and QA auditors. He'll also highlight, through real-world examples, some of the pitfalls and pressure points you can expect as you build your TMF.

Click here for more information on the audio conference; or click here to order the CD online or call 1-800-688-2421 (1-404-262-5474) to order the CD recording (MP3 format). Please mention priority code 11T08510.

Is the FDA asking too much of your 510(k)?

A 510(k) submission is supposed to be a straightforward procedure. Increasingly, however, the FDA is asking for more evidence, and sometimes more than that to which it is entitled under the substantial equivalence standard. With the increase in agency requests, the process is becoming "PMA Lite."

In this 90-minute audio conference CD, device submissions expert Mark DuVal will discuss what FDA is asking for in 510(k) submissions, and how you can effectively respond to FDA's ever increasing demands for more medical and scientific information. You'll also learn how to hold FDA's feet to the fire in negotiations, and request that agency officials adhere to the "least burdensome" principles.

Click here for more information on the audio conference; or click here to order online or call 1-800-688-2421 (1-404-262-5474) to order the CD recording (MP3 format). Please mention priority code 11T08513.

Compassionate Use: Changes You Should Make Following Gunvalson et al. v. PTC Therapeutics

A new 45-minute Audio Briefing CD from BioWorld Today and Medical Device Daily

On August 20, 2008, a U.S. District judge ordered PTC Therapeutics to supply a drug still in Phase II trials to Jacob Gunvalson, who has muscular dystrophy. PTC had declined to enroll Gunvalson in a trial or obtain a treatment IND under 21 CFR 312.34, despite alleged promises to his family to do so.

Should you make changes to your compassionate use policies in light of this case? Should you change how you communicate with patients? What about the FDA's proposed rule on treatment INDs, and recent actions by Abigail Alliance?

In this special 45-minute audio briefing CD, clinical trial expert attorney Clint Hermes will examine the latest developments in compassionate use so you can minimize legal risk and stay compliant.

Click here for more information on the audio conference CD; or click here to order CD online or call 1-800-688-2421 (1-404-262-5474) to order the CD recording (MP3 format). Please mention priority code 11T08514.

Duty to Warn Case Studies: Could Protecting Patients Increase Your Liability?

Who has the duty to warn of danger caused by drugs? Not long ago, the answer was simple: doctors. Not anymore.

In July 2007, the "learned intermediary" principle was rejected when the West Virginia Supreme Court ruled that, due in part to DTC advertising, "manufacturers of prescription drugs are subject to the same duty to warn consumers about the risks of their products as other manufacturers." One year later, and it is still unclear what impact this ruling will have in other states.

Likewise, pharmacists' duty to warn can vary from none to significant, depending on jurisdiction.

Do you know what your duty to warn is? Do you know that the actions you or your company take can increase or change your duty? Do you know what they are? In this 90-minute audio conference CD, legal author and expert Roseann Termini will guide you through this confusing landscape and provide strategies to protect against liability.

Click here for more information on the audio conference; or click here to order the CD online or call 1-800-688-2421 (1-404-262-5474) to order the CD recording (MP3 format). Please mention priority code 11T08515.

The EU Clinical Trials Directive and Beyond: What You Must Know to Get Your Trial Approved

There are benefits to conducting a trial in the EU—but companies that don't understand the complicated process and the many ramifications of the Clinical Trials Directive (2001/20/EC) risk wasting significant time and money, and may still not get their drug approved.

Each member state interprets the directive differently, requiring sponsors and sites to juggle 27 sets of rules. National Competent Authorities can impose additional, onerous requirements before approving a trial.

And once a phase is complete, sponsors have to go through the process again, since individual studies, not investigational drugs, are approved.

In this 90-minute audio conference CD, Francis P. Crawley will show attendees what they need to know about the directive to effectively navigate the European clinical trial environment.

Click here for more information on the audio conference; or click here to order online or call 1-800-688-2421 (1-404-262-5474) to order the CD recording (MP3 format). Please mention priority code 11T08516.

Medicare and Clinical Trials: What Can I Truly Bill to CMS?

Medicare covers "routine costs of qualifying clinical trials" and "reasonable and necessary items and services used to diagnose and treat complications arising from participation in all clinical trials."

It isn't that simple, however. Medicare does not consider experimental and investigational care to be "reasonable" or "necessary." What is "routine" in the real world could be very different from what CMS will accept. Even what can qualify as a complication, and whether it occurred through clinical trial participation isn't clear cut.

But pharmaceutical development companies and research institutions alike must know exactly what is eligible for reimbursement. Companies that don't face cost overruns, and may waste development resources. Hospitals and other research organizations that bill incorrectly risk fines and legal action by the OIG (remember Rush University Medical Center?).

Back by popular demand, clinical trial expert Mark Barnes will examine what CMS says, then explain what it means. He'll clarify confusing language and identify areas of compliance concern, all to show attendees what can, and can't, be billed to Medicare.

Click here for more information on the audio conference; or click here to order online or call 1-800-688-2421 (1-404-262-5474) to order the CD recording (MP3 format). Please mention priority code 11T08517.

Quality Risk Management Case Studies: Taking it to the Next Level

How are your pharmaceutical industry colleagues using Quality Risk Management (QRM) in order to ensure compliance and improve processing?

In this 90-minute audio conference CD, industry insiders Kristin Murray and Stephen Reich will show you what they've done to move beyond simple QRM applications and into more progressive areas. Through two real-world case studies, they will show how to implement ICH Q9, and how to use QRM, to conquer complex quality issues and challenge long-standing industry approaches.

Click here for more information on the audio conference; or click here to order online or call 1-800-688-2421 (1-404-262-5474) to order the CD recording (MP3 format). Please mention priority code 11T08518.

Clinical Vendor Audits: How to Get the Answers You Need

Whether you're pre-qualifying new providers, or conducting a return audit, you need a process to get the facts. Let's be honest CROs and SMOs know what you "want to hear." And if you don't follow a thorough, methodical procedure, you could miss important details that will hurt you later.

Enrollment goals may not be met. You may not get clean data. Or worse, protocol may be violated, resulting in 483 findings or patient injury.

Make sure your vendor audits give you the information you need. In this 90-minute audio conference CD, experts Carl Anderson and Tania Johnstone Issa will provide the game plan you need to execute audits effectively.

Click here for more information on the audio conference; or click here to order CD online or call 1-800-688-2421 (1-404-262-5474) to order the CD recording (MP3 format). Please mention priority code T08519_6378.

Corrosion Testing of Medical Devices: Proving Biocompatibility

Before a medical implant device can be sold, the device's manufacturer must demonstrate that the implant will be biocompatible—it must not adversely affect its host environment (the patient's body), nor should it be adversely affected by the environment. Corrosion resistance is a key factor in biocompatibility.

In this 90-minute audio conference CD, Dr. Shari Rosenbloom and Dr. Esra Kuş will examine the types of corrosion most commonly encountered in medical devices. They will review the FDA's guidance on in vitro corrosion testing to provide a better understanding of what the FDA is looking for from device manufacturers in demonstrating the corrosion resistance of their devices. They will discuss the various testing methods available, and when each test method should be used. They will show how to design an appropriate testing program, and how to interpret the results of testing. They will also present the lessons learned from experiences with the FDA's response to results submitted from in vitro corrosion testing.

Click here for more information on the audio conference; or click here to order the CD online or call 1-800-688-2421 (1-404-262-5474) to order the CD recording (MP3 format). Please mention priority code T08520-6701.

False Claims Act: Ensuring and Showing Compliance as Enforcement Increases

In the last 12 months, more than $2 billion has been paid by pharmaceutical, medical device, and healthcare companies to settle False Claims Act (FCA) disputes. With recent changes in FCA enforcement, and legislation pending to change the FCA, do you know how the government plans to wield this powerful weapon in the future?

In this 90-minute audio conference CD, health care fraud and abuse expert Laura Laemmle-Weidenfeld will examine the fast changing world of health care fraud and abuse, with an emphasis on developments under the FCA, and provide strategies on how you can maintain and prove compliance.

Click here for more information on the audio conference; or click here to order the CD online or call 1-800-688-2421 (1-404-262-5474) to order the CD recording (MP3 format). Please mention priority code T08521-6706.

Clinical Trial SOPs: Developing for Compliance and Usability

From a warning letter issued June 1, 2008:

"Your monitoring SOP does not address approving, documenting, and reporting of protocol deviations. Please add protocol deviations to your SOP."

Will your SOPs withstand FDA scrutiny? In this 90-minute audio conference CD, clinical research expert Erich Jensen will examine the common components of an SOP, and identify potential compliance concerns. He'll take you step by step though SOP development and production, and show where your efforts should be focused. He'll also show the payoff for these efforts through real-life case histories.

Click here for more information on the audio conference; or click here to order the CD online or call 1-800-688-2421 (1-404-262-5474) to order the CD recording (MP3 format). Please mention priority code T08522-6711.

Extreme Informed Consent: 8 Novel Ways to Improve the Process

From three recent FDA warning letters issued for informed consent violations:

Subject signed a sub-study consent document, but did not sign an informed consent document for participation in the main study.

Study consent forms for subjects enrolled in the study were dated after the study procedure was performed.

For 30 of the 34 subjects enrolled, informed consent was not obtained or documented by the use of a written consent form approved by the IRB ...

32 warning letters have been issued in the last 12 months to sponsors, investigators, and IRBs for informed consent problems. Despite clear language from the FDA on what proper consent is, and additional guidance from the agency and ICH, violations still occur.

How do informed consent procedures keep failing? And how do we fix them?

In this 90-minute audio conference CD, Darren McDaniel, founder of Coast IRB, will examine the current regulations, violations and case law surrounding the inadequacies of modern-day informed consent. He will present real-life medical case studies and a thorough look at the spirit and meaning of informed consent outside of "dotting I's and crossing T's." He will also present 8 practical ways to radically improve informed consent.

Click here for more information on the audio conference; or click here to order the CD online or call 1-800-688-2421 (1-404-262-5474) to order the CD recording (MP3 format). Please mention priority code T08523-6716.

How to Comply with New Medical Device Postmarket Surveillance Requirements

For medical device regulatory professionals, postmarket surveillance procedures were once "nice to know" information. Thanks to FDAAA, they are "need to know," since the FDA can now compel manufacturers to conduct postmarket surveillance.

And you need to know fast once the agency issues a postmarket surveillance order, you have just 30 days to develop a PS plan and submit it to CDRH for approval.

Be ready. In this 90-minute audio conference CD, former FDA Regulatory Counsel, Elaine Tseng, will tell you what you need to know to comply with a postmarket surveillance order. She'll describe postmarket surveillance plans that can meet FDA requirements, and can be "least burdensome" to implement. She'll also explain the many items that should be in your PS plan, how to manage communication with the FDA and more.

Click here for more information on the audio conference; or click here to order the CD online or call 1-800-688-2421 (1-404-262-5474) to order the CD recording (MP3 format). Please mention priority code T08524-6721.

Negotiating Clinical Trial Agreements: Strategies to Protect Your Business Interests

Perhaps your company has been outsourcing trials for decades. Or maybe you are just starting. Either way, you know this is one of the most important and most challenging aspects of the business. Get the wrong contract in place or even have a single unfriendly provision in the agreement, and you could be unable to protect your IP, be unable to access your trial data, or take on some of the trial site's risks in subject injury lawsuits.

To protect your company, listen to this fast-paced, information-packed audio conference with attorney Katherine Leibowitz. She'll examine the biggest business issues in contracting with sites and provide real-world solutions on how to deal with them. She'll provide realistic, practical guidance to help you create terms sites will accept, but will protect your interests.

Click here for more information on the audio conference; or click here to order online or call 1-800-688-2421 (1-404-262-5474) to order the CD recording (MP3 format). Please mention priority code T08525-6726.

Root Cause Analysis: Tools for Finding True Root Cause

Recent FDA warning letters tell the story:

Your investigations are incomplete in that they did not identify a root cause...

We are concerned that thorough investigations are not being conducted on these complaints to determine that a root cause is not due to the above validation deficiencies.

You did not take the next step necessary to correct this problem on a process-wide level, however, which is to determine the root cause of these anomalies.

Under the FDA's risk-based CAPA requirements, you need a documented system for discovering the root cause of system failures, process exceptions and non-conformances. Your root cause analysis should identify why things go wrong, then make sure they don't happen again.

So how do you conduct an effective root cause analysis (RCA)? In this 90-minute audio conference, GMP and human performance expert Vivian Bringslimark will share the expertise she has gained through hundreds of failure investigations. She'll tell you who should be in your RCA team and the common errors you could encounter. She'll lead you through a tool kit of proven methods of root cause analysis.

Additionally, each registered site will receive the following materials:

• A high level Root Cause and CAPA Process Flow Diagram
• "4M" Fishbone Diagram to guide investigation questions and ensure all possible causes are explored
• Job Aid for exploring "environmental factors" discussed during audio conference

Click here for more information on the audio conference; or click here to order online or call 1-800-688-2421 (1-404-262-5474) to order the CD recording (MP3 format). Please mention priority code T08526-6731.

FDA Inspections: Be Ready

With a new Administration, and a new FDA Commissioner, inspections are almost certain to increase. And with the enforcement powers granted under FDAAA, being prepared for an inspection is now more important than ever.

Those firms that have a good understanding of its compliance profile, with staff properly trained, is more likely to have a successful inspection than a firm that is unprepared.

In this 90 minute audio conference, compliance attorney and expert Cathy Burgess will educate you and your staff on what it takes to pass an FDA inspection, both in terms of meeting FDA regulations, and in management of the inspection process itself.

Click here for more information on the audio conference; or click here to order online or call 1-800-688-2421 (1-404-262-5474) to order the CD recording (MP3 format). Please mention priority code T09527-7123.

CAPA: 8 Steps to Achieve Compliance

59 warning letters have been issued over the last 12 months by the FDA to medical device companies for inadequate corrective and preventive action (CAPA) procedures. These warnings have gone to the largest companies (e.g. GE, Philips, CR Bard) as well as some of the smallest.

This 90-minute audio conference will help companies develop and implement a compliant and effective CAPA system. It will help attendees analyze processes and work operations, guide them on making concessions and prioritizing resources. Finally, it will show them an 8-step workflow for executing the CAPA process from start to finish, and provide insight and strategies for success at each step. It will also show what to do if the CAPA process fails to prevent or correct a given action.

Click here for more information on the audio conference; or click here to order online or call 1-800-688-2421 (1-404-262-5474) to order the CD recording (MP3 format). Please mention priority code T09528-7128.

Design Control: Ensuring Compliance During Device Development

Your firm provided no documentation of validation of the embedded software in the device.

Your limited design procedures lack detail and specificity to (your) operations and do not include a procedure for design planning.

The [specification] has not been updated to reflect the [analysis] requirement to display a message when PET slices are missing from a loaded dataset... the Software Requirements Specification for the product was updated in September 2007; however, this design change was not identified or implemented.

These are from just three of the 48 warning letters issued in the last 12 months by the FDA citing 21 CFR 820.30—Design Controls. It's clear from these letters that the Agency will use design control for quality system problems broad and narrow, and from operation to documentation—even computer system validation.

Ensure that your design control systems are compliant. In this 90-minute audio conference, former FDA Investigator Dennis Moore will provide an in-depth look at the design control process. He will discuss risk management during development, bettering your design reviews, and how to better define design plans and contract manufacturer roles and responsibilities. Pain points in design transfer, from research and development into production will be identified. Finally, key differences between ISO 13485:2003 and the QS Reg. will be addressed. All this will be provided to show what your firm should do to keep the FDA happy.

Click here for more information on the audio conference; or click here to order online or call 1-800-688-2421 (1-404-262-5474) to order the CD recording (MP3 format). Please mention priority code T09530-7138.

90 Days Until Destruction: How to Release an FDA Import Hold

When: Wednesday, January 28, 2009;
What Time: 1pm to 2:30pm ET
Where: Your office or conference room
Cost: Just $325 per listening site no matter how many people are in the room!

In August 2008 alone, more than 1,900 shipments into the U.S. were refused by the FDA – more than five times the number refused just one year before.

For shipment owners, getting their product released can be a frustrating and time consuming process. Those that fail to do so could have their product destroyed in as little as 90 days, meaning, in some cases, millions of dollars lost.

But it doesn't have to end that way. In this 90-minute audio conference, attorneys Deborah Shelton and Philip Gallas, and customs broker Joy Peterson will explain what companies must do to get a hold lifted, and provide strategies for managing the communication process with the FDA and Customs.

Click here for more information on the audio conference; or click here to order online or call 1-800-688-2421 (1-404-262-5474) to order the CD recording (MP3 format). Please mention priority code T09532-7148.

New HHS and FDA: How Will it Affect Pharma?

When: Thursday, January 29, 2009;
What Time: 2pm to 2:45pm ET
Where: Your office or conference room
Cost: Just $199 per listening site no matter how many people are in the room!

President Obama's Administration promises to impact many aspects of American business—perhaps nowhere more than the pharmaceutical and medical device industries.

So what can you expect? In this 45-minute audio briefing, former FDA deputy associate commissioner for Regulatory Operations Steve Niedelman and attorney Cathy Burgess will provide insider insight into how your work could change in the coming months.

Click here for more information on the audio conference; or click here to order online or call 1-800-688-2421 (1-404-262-5474) to order the CD recording (MP3 format). Please mention priority code T09533-7153.

Trial Master File: Can You Pass FDA Inspection?

When: Tuesday, February 3, 2009
What Time: 1pm to 2:30pm ET
Where: Your office or conference room
Cost: Just $325 per listening site no matter how many people are in the room!

Your clinical trial has zero chance of passing an FDA inspection or QA audit if your Trial Master File (TMF) is not in order.

The FDA frequently states that if compliance isn't documented, it didn't happen. Your TMF serves as living proof that you are adhering to GCP, and that your quality system is in a state of control.

Beyond simply being a get out of jail free card, a well-maintained TMF can make trial management easier; with a typical TMF containing thousands of pages of documentation, you could easily save, or lose, hundreds of hours over the life of a trial searching for individual pieces of knowledge.

In this 90-minute audio conference, clinical trials expert Carl Anderson will provide guidance on the TMF. He'll describe the steps to take throughout a trial to ensure your TMF will pass inspection by FDA investigators and QA auditors. He'll also highlight, through real-world examples, some of the pitfalls and pressure points you can expect as you build your TMF.

Click here for more information on the audio conference; or click here to order online or call 1-800-688-2421 (1-404-262-5474) to order the CD recording (MP3 format). Please mention priority code T09534-7158.

Will the FDA Approve Your Drug's Proprietary Name?

When: Tuesday, February 10, 2009;
What Time: 2pm to 2:45pm ET
Where: Your office or conference room
Cost: Just $199 per listening site no matter how many people are in the room!

On November 24, 2008, the FDA released a draft guidance on proprietary drug name evaluations. While the document details the process for filing a name review request, it is less clear on what it takes to get a name approved.

The Agency rejects one of every three names submitted, making decisions impacting your drug's viability based on vague concepts such as if the drug name is "fanciful".

Don't let all your efforts go to waste. In this 45-minute audio briefing, attorneys Marc Shapiro and Susan Matthees of Hyman, Phelps & McNamara, will examine the November, 2008 draft guidance, and explain the process and important considerations for getting a proposed proprietary name approved.

Click here for more information on the audio conference; or click here to order online or call 1-800-688-2421 (1-404-262-5474) to order the CD recording (MP3 format). Please mention priority code T09537-7173.

Nanoparticle Regulation: What the FDA, EPA and OSHA Plan to Do

For manufacturers that include nanotechnology in their products, the days without special regulation will likely come to an end soon.

In recent months, both the FDA and EPA have examined their non-regulation of nanoparticles, and have taken actions that could change that. OSHA and NIOSH are actively investigating nanoparticles safety. With each new product, from industrial filters to anti-wrinkle creams made with nanoparticles, state agencies take more interest in developing rules and guidelines. Do you know their plans?

Understand the risks, and be ready to manage them. In this 90-minute audio conference, experts Brian Clark and Edward Allera will describe the coming regulatory environment, and the current thinking of the major government players. They'll examine statements and actions by FDA, EPA, and OSHA to help you prepare for future regulation. They'll also review the guidelines put forth by NNI, and provide help in designing safety procedures to reduce the risk of litigation.

Click here for more information on the audio conference; or click here to order online or call 1-800-688-2421 (1-404-262-5474) to order the CD recording (MP3 format). Please mention priority code 11T09536-7168.

Adverse Events Reporting: Prove Compliance and Ensure Patient Safety

Adverse Events (AE) happen multiple times in nearly every clinical trial. How you deal with them is what matters. But just how you report them, and to whom you report them, can be confusing.

Is it a Serious AE? Is it also an Unanticipated Problem? Are you subject only to FDA regulations? Common Rule? NIH requirements? IRB demands?

How do you document and file? How do you prove you did everything right?

Answer these questions wrong, and you could face FDA warning letters, have your trials stopped, or your product denied approval.

In this 90-minute audio conference, clinical trials expert Mark Barnes will detail the AE reporting process what to report, what not to report, and how, when, and to whom reports should be made. He'll tell you what the regulations and guidances don't, to show how to document and prove compliance, and to ensure patient safety.

Click here for more information on the audio conference; or click here to order online or call 1-800-688-2421 (1-404-262-5474) to order the CD recording (MP3 format). Please mention priority code 11T09538-7178.

Clinical Trial Recruitment: What Should Sponsors Do?

Recruiting subjects for clinical trials is the exclusive domain of sites, right?

Wrong. What sponsors do can have tremendous impact, positively or negatively, on recruitment. And, with it becoming more difficult each year to sign up enough patients to start trials on time, you need to do all you can to meet that most important milestone: Last patient in.

In this 90-minute audio conference, clinical trials expert Terry Stubbs will describe what sponsor and CROs should, and should not, do to get the best work out of sites. She will define what you need to know about your site s operation, and how to find out if their recruiting efforts will be effective. She ll also show how to structure study start-up and patient milestones to maximize recruitment.

Click here for more information on the audio conference; or click here to order online or call 1-800-688-2421 (1-404-262-5474) to order the CD recording (MP3 format). Please mention priority code 11T09540-7188.

Off-Label Promotion: Be Careful, Be Very Careful

DDMAC... has become aware of oral statements made by an AstraZeneca LP (AZ) sales representative on January 3, 2008, to a healthcare professional... The representative and the mailing recommended or suggested a use for Seroquel and Seroquel XR that has not been approved by FDA.

FDA Untitled letter, December 1, 2008

It's a letter no compliance officer, executive, or anyone else at a drug or device company wants to receive. You believe your sales staff understands the rules on off-label promotion, and will fully comply. Yet every year, FDA-regulated companies pay tens or hundreds of millions of dollars to the DoJ over alleged off-label promotion.

Make sure your people know what is, and is not, acceptable. In this 90-minute audio conference, attorney Alan Minsk will examine the many laws that apply to off-label promotion, describe the risks to consider when interacting with healthcare professionals, and will provide strategies to develop an effective compliance program.

Click here for more information on the audio conference; or click here to order online or call 1-800-688-2421 (1-404-262-5474) to order the CD recording (MP3 format). Please mention priority code 11T09539-7183.

483s, Warning Letters, Recalls, and other Common FDA Enforcement Actions

In 2007, the agency issued 5,100 483s and 471 warning letters. 5,585 recalls were issued.

Chances are, if you are in the industry long enough, you'll have to deal with a 483, a warning letter, or a recall. But just because they are common, that doesn't mean they should be taken lightly.

In this lively 90-minute audio conference, attorney and educator Roseann Termini will, through case studies and interactive exercises, help attendees understand these enforcement actions, and show how to respond to minimize liability risk.

Click here for more information on the audio conference; or click here to order online or call 1-800-688-2421 (1-404-262-5474) to order the CD recording (MP3 format). Please mention priority code 11T09544-7206.

Paediatric Clinical Trials in the EU: Regulatory, Scientific, and Ethical Challenges!

Developing a new drug that can be taken by children in the EU? Then you must understand, and comply with the EU Paediatric Regulation. On January 26, 2009, the Paediatric Regulation was extended to drugs already on the market seeking "a new indication, pharmaceutical form or route of administration."

In this new 90-minute BioWorld Today audio conference, Francis P. Crawley, the Executive Director of the Good Clinical Practice Alliance, Europe (GCPA) and a WHO expert in ethics, will share lessons learned from the past two years of pediatric clinical trials in the EU.

In this 90-minute audio conference, clinical trials expert Mark Barnes will detail the AE reporting process what to report, what not to report, and how, when, and to whom reports should be made. He'll tell you what the regulations and guidances don't, to show how to document and prove compliance, and to ensure patient safety.

Click here for more information on the audio conference; or click here to order online or call 1-800-688-2421 (1-404-262-5474) to order the CD recording (MP3 format). Please mention priority code 11T09541-7193.

Out of Your Hands: Import Holds and Alerts, Product Seizures, and Injunctions

In 2007, the FDA refused nearly 50,000 imports, imposed numerous injunctions, and seized millions of dollars in product. How do you respond to the FDA when they have control of your product?

In this lively 90-minute audio conference CD, Attorney and educator Roseann Termini will, through case studies and interactive exercises, help attendees understand these enforcement actions, and show how to respond to minimize liability risk.

Click here for more information on the audio conference; or click here to order online or call 1-800-688-2421 (1-404-262-5474) to order the CD recording (MP3 format). Please mention priority code 11T09545-7209.

510(k)—Essentials of Gaining FDA Marketing Clearance

Developing a new drug that can be taken by children in the EU? Then you must understand, and comply with the EU Paediatric Regulation. On January 26, 2009, the Paediatric Regulation was extended to drugs already on the market seeking "a new indication, pharmaceutical form or route of administration."

The 510(k) submission process is preferred over a PMA for those devices that qualify. Would you know which 510(k) to use? What is involved or how do you plan for a submission? Are you sure your submission can get clearance from the FDA?

In this 90-minute audio conference CD sponsored by Medical Device Daily, device submissions expert Karen Bannick will discuss what is expected in 510(k) submissions and how you can effectively respond to the agency's ever increasing demands for more medical and scientific information.

Click here for more information on the audio conference; or click here to order onlineor call 1-800-688-2421 (1-404-262-5474) to order the CD recording (MP3 format). Please mention priority code 11T09542-7198.

The Big Guns: Disgorgement, Civil Penalties, and Criminal Prosecution

In 2007, FDA's Office of Criminal Investigations (OCI) netted 496 arrests, 344 convictions, and $1.92 billion in fines and restitution.

Hopefully, you will never be amongst these numbers. And one of the best ways to avoid it is to see the warning signs, and to respond quickly and appropriately.

In this lively 90-minute audio conference, attorney and educator Roseann Termini will, through case studies and interactive exercises, help attendees understand these enforcement actions, and show how to respond to minimize liability risk.

Click here for more information on the audio conference CD; or click here to order online or call 1-800-688-2421 (1-404-262-5474) to order the CD recording (MP3 format). Please mention priority code 11T09546-7212.

Understanding and Responding to FDA Enforcement Actions
(Can They REALLY Do That?) Three Session Audio Conference CD Series

A New 3 Part Comprehensive FDA Audio Conference Series
Offering you a savings of over $200

Need to get your people up to speed on the FDA's enforcement powers, and how your team should respond to Agency actions? Whether they are new to regulatory affairs, will be involved in an inspection, or just need a refresher, the FDA Enforcement interactive audio conference series will give them the basics they need, along with the latest on the FDA's new powers under FDAAA.

Click here for more information on the audio conference; or click here to order online or call 1-800-688-2421 (1-404-262-5474) to order the CD series recordings (MP3 format). Please mention priority code 11T09547-7217.

Clinical Research in India: The Rules and Realities of Trial Approval

More than 800 clinical trials are currently being conducted in India, with more on the way. As the country grows into a mature destination for pharmaceutical development and sales, regulators are developing new GCPs and increasing enforcement.

Do you know what it takes to get a trial approved in India, and ensure compliance through the study's duration? In this 90-minute audio conference, clinical trials expert Dr. Munish Mehra will describe the rules, and the realities, of clinical trial compliance in the world's largest democracy. He'll show how trial conduct is similar to the Western approach, and where things differ. He'll show you the documents you need, the policies you need to have in place, and the people who make approval possible.

Click here for more information on the audio conference; or click here to order online or call 1-800-688-2421 (1-404-262-5474) to order the CD recording (MP3 format). Please mention priority code 11T09543-7203.

Promotion at Trade Shows and Medical Meetings: Not If, But How

Promoting prescription drugs and devices at trade shows and medical meetings is an essential element to successful marketing. However, questions of regulatory gray areas are imminent. Regardless of whether it is well intended or not, an error in developing promotions in these forums can lead to serious compliance and legal issues.

In this 90-minute BioWorld Today and Medical Device Daily audio conference, attorney William Kitchens will explain what legitimate promotional activity in these forums is, and provide guidance on structuring your promotions to avoid regulatory headaches.

Click here for more information on the audio conference CD; or click here to order the CD online or call 1-800-688-2421 (1-404-262-5474) to order the CD recording (MP3 format). Please mention priority code 11T09549-7227.

Wyeth v. Levine: What You Should Do Now Regarding Preemption

On March 4, 2009, the Supreme Court surprised many by ruling 6-3 against prescription drug preemption in Wyeth v. Levine.

So what do you do about your drug labeling? Will you need to expand your drug warnings to reduce your liability risk? How should you manage communication on labeling changes with the FDA? Will tort lawyers be outside your doors with hundreds of new lawsuits? Will Levine embolden state attorneys general to pursue actions against drug companies?

In this 45-minute audio briefing, attorneys Linda Pissott Reig and John T. Chester will explain how the Supreme Court's ruling directly impacts your business, and what you should do today as a result.

Click here for more information on the audio conference; or click here to order the CD onlineor call 1-800-688-2421 (1-404-262-5474) to order the CD recording (MP3 format). Please mention priority code 11T09553-7249.

Parallel Trade in the EU: How to Comply with Unclear Requirements

On September 16, 2008, the European Court of Justice ruled on parallel trade after GlaxoSmithKline refused to fill orders placed by certain distributors.

But the ruling left many questions unanswered. The Court held that pharma companies can refuse to supply "unusual" orders from wholesalers. But what constitutes "unusual" is left to individual countries to decide.

So how do you deal with the uncertainty created by this latest ruling, while complying with mandates to ensure a safe drug supply? In this 90-minute audio conference, attorneys Edward Miller and John Wilkinson will analyze the developing law in this area, explain the key concepts behind the different distribution models in the pharma industry, and speculate about what comes next in the parallel distribution debate.

Click here for more information on the audio conference; or click here to order online or call 1-800-688-2421 (1-404-262-5474) to order the CD recording (MP3 format). Please mention priority code 11T09550-7232.

clinicaltrials.gov—What You Need to Know

You know you must register your trials on clinicaltrials.gov. You know you face fines, up to $10,000 per day, if you don't register them exactly as the FDA wants.

Do you know exactly what the agency wants to see?

In this 90 minute audio conference, expert Mark Barnes will show how to properly register your clinical trials on clinicaltrials.gov. He'll examine the common pitfalls and areas of confusion, and explain the latest developments from the April 20, 2009 NIH meeting on clinical trial registration.

Click here for more information on the audio conference CD; or click here to order the CD online or call 1-800-688-2421 (1-404-262-5474) to order the CD recording (MP3 format). Please mention priority code 11T09552-7242.

Biosimilars in the U.S.: Is This (finally) the Year?

Since 2006, when the EU approved the sale of biosimilars, the U.S. has debated, discussed, and promised a pathway for generic biologics.

So what makes 2009 different? President Obama and Congress have made affordable healthcare a priority. This, combined with new HHS, CMS, and FDA leadership ensures that a genuine pathway for FDA-approved biosimilars will be a priority.

Maybe that's why, on February 12, Merck purchased follow-on biologics maker Insmed for $130 million.

What should you be doing now to be ready for biosimilars in the U.S.? In this 90-minute audio conference CD, attorney Arnie Friede will examine the biosimilars legislative discussion, and explain how that will soon impact your business and regulatory activity.

Click here for more information on the audio conference CD; or click here to order online or call 1-800-688-2421 (1-404-262-5474) to order the CD recording (MP3 format). Please mention priority code 11T09551-7237.

GMP Internal Audits: How to Ensure Compliance and Quality

When: Wednesday, May 6, 2009;
What Time: 1pm to 2:30pm ET
Where: Your office or conference room
Cost: Just $325 per listening site no matter how many people are in the room!

"You state in your July 10, 2008 response that your firm continues to undergo annual external audits with the most recent audit conducted before our last inspection conducted in June 2008, and your firm's compliance history raises concerns about the effectiveness of the audits."

The FDA is clear in this, and in other warning letters issued during the last year: "It is your responsibility to conduct a comprehensive audit of your facility and operations and ensure compliance with all requirements."

Of course, you have an internal audit program in place. But are you sure you have everything covered? Are you sure you won't receive a 483 in spite of your audit program? Are you catching deviations before products leave the facility? In this 90-minute audio conference, FDA veteran Steve Niedelman and expert attorney Cathy Burgess will provide insight on internal auditing for compliance, and how to ensure your firm consistently produces and distributes high quality pharmaceutical products.

Click here for more information on the audio conference; or click here to order online or call 1-800-688-2421 (1-404-262-5474) to order the CD recording (MP3 format). Please mention priority code T09556-7267.

Profiting from the 505(b)(2) Drug Approval Process

When: Thursday, May 7, 2009
What Time: 1pm to 2:30pm ET
Where: Your office or conference room
Cost: Just $325 per listening site no matter how many people are in the room!

The era of the blockbuster drug is over. Pipelines are drying up, thousands of jobs are being cut. To thrive, or even survive in this market, you have to be smart.

The FDA's 505(b)(2) approval pathway, which lets companies modify and reposition existing drugs for marketing clearance, is a smart choice. But you must understand how it works.

In this 90-minute interactive audio conference, expert Ken Phelps will show how to navigate the intricate 505(b)(2) process, and how to use the distinctions to make money and save time.

Click here for more information on the audio conference; or click here to order online or call 1-800-688-2421 (1-404-262-5474) to order the CD recording (MP3 format). Please mention priority code T09554-7255.

Extreme Informed Consent: 8 Novel Ways to Improve the Process

When: Wednesday, May 13, 2009
What Time: 2pm to 3:30pm ET
Where: Your office or conference room
Cost: Just $325 per listening site no matter how many people are in the room!

28 warning letters have been issued in the last 12 months to sponsors, investigators, and IRBs for informed consent problems. Despite clear language from the FDA on what proper consent is, and additional guidance from the agency and ICH, violations still occur.

How do informed consent procedures keep failing? And how do we fix them?

In this 90-minute audio conference, Clint Hermes will examine the current regulations, violations and case law surrounding the inadequacies of modern day informed consent. He will present real-life medical case studies and a thorough look at the spirit and meaning of informed consent outside of "dotting I's and crossing T's." He will also present 8 practical ways to radically improve informed consent.

Click here for more information on the audio conference; or click here to order online or call 1-800-688-2421 (1-404-262-5474) to order the CD recording (MP3 format). Please mention priority code T09555-7261.

FREE Audio Conference: Crisis Communications for FDA Regulated Companies

BioWorld Today and Medical Device Daily would like to thank our past customers and invite members of both the biotech and med-tech industries to enjoy this new FREE audio conference ...

When: Tuesday, May 19, 2009
What Time: 1pm to 2:30pm ET
Where: Your office or conference room
Cost:  FREE

Medical device companies are being investigated by the SEC, a Phase III clinical trial failed to produce results for a biotech seeking new investors, and food manufacturers recalled food containing peanut butter and pistachios. These companies are facing a public relations crisis and are subject to FDA scrutiny. But the companies that have a plan in place before a crisis emerges have an easier time satisfying stakeholders while minimizing risk and staying compliant.

Crisis communications expert Jennifer Johnson describes how to develop ongoing communication practices with internal and external audiences in preparation for crisis situations in this 90-minute BioWorld Today and Medical Device Daily audio conference.

Click here for more information on the audio conference; or click here to sign up online or call 1-800-688-2421 (1-404-262-5474) to sign up or ask about other package options including a CD of the event. Please mention priority code T09557-7273.

DDMAC Enforcement Spikes: What You Need to Know to Be Compliant

Since March 2008, DDMAC has issued 39 warning and untitled letters to drug manufacturers on all sorts of advertising, from professional slide decks to DTC commercials. And enforcement can go beyond a "cease dissemination" request. Bayer, for example, must now submit Yaz commercials to the FDA for approval before they run, and is spending $20 million on corrective advertising.

In this 90-minute audio conference, expert attorneys Vernessa Pollard and Joshua Glasser will provide insight on current DDMAC enforcement trends. Examining the violative ads and DDMAC response letters point by point, their guidance will help you reduce the risk of FDA enforcement, corrective action, bad press and diminished brand reputation due to your advertising efforts.

Click here for more information on the audio conference CD; or click here to order online or call 1-800-688-2421 (1-404-262-5474) to order the CD recording (MP3 format). Please mention priority code 11T09558-7279.

Massachusetts' New 'Pharmaceutical and Medical Device Manufacturer Conduct' Law and How to Comply

In this special 45-minute BioWorld Today and Medical Device Daily audio briefing, attorney Keith Korenchuk will discuss the new rule, highlighting changes from the proposed and final regulations, as well as compare the Massachusetts disclosure law and regulations to the proposed Physician Payments Sunshine Act (Sunshine Act) and to the current PhRMA Code on Interactions with Healthcare Professionals (PhRMA Code).

Click here for more information on the audio conference; or click here to sign up online or call 1-800-688-2421 (1-404-262-5474) to sign up or ask about other package options including a CD of the event. Please mention priority code 11T09559_7285.

How to Budget for Clinical Trials

Budgeting is one of the most challenging aspects of clinical trials. With so many moving parts and unknowns (subject recruiting, facilities, equipment and more), arriving at an accurate figure, with confidence, is next to impossible.

How do you set fair and equitable milestones for payment? How do you negotiate payments with third-party providers? And how can you be sure that you are compliant with requirements of Medicare and other payors?

In this 90-minute audio conference CD, clinical trials expert Mark Barnes will provide proven guidance on effectively and accurately budgeting for a clinical trial.

Click here for more information on the audio conference; or click here to order online or call 1-800-688-2421 (1-404-262-5474) to order the CD recording (MP3 format). Please mention priority code 11T09562-7297.

Managing Communication Before Device Approval to Ensure Off-Label Compliance

Clearly you can't promote a device subject to an IDE, but how do you enroll clinical investigators and patients? What if you describe an indication that might not be approved? How do you describe your pending device to potential investors, or announce it to your industry peers or press at a trade show?

In a new Medical Device Daily audio conference CD, expert attorney Bradley Merrill Thompson examines risks in communication at each stage, from early development to just before approval. He shows how to convey truthful information on your device, while reducing chances of violating off-label promotion laws.

Click here for more information on the audio conference; or click here to order online or call 1-800-688-2421 (1-404-262-5474) to order the CD recording (MP3 format). Please mention priority code 11T09563-7303.

Hatch-Waxman in 2009: Shaping Your Strategies for Recent and Upcoming Government Action

PLEASE NOTE DATE CHANGED FROM: Tuesday, June 9, 2009

When: Thursday, June 11, 2009
What Time: 1pm to 2:30pm ET
Where: Your office or conference room
Cost: Just $325 per listening site no matter how many people are in the room!

The 1984 Hatch-Waxman legal framework under which generic drugs are approved and patents for brand-name drugs challenged has been fundamentally altered in recent years by new legislation, court decisions and FDA actions. The changes to the core elements of the Hatch-Waxman process—abbreviated new drug applications (ANDAs), ensuing Paragraph IV patent litigation, and available market exclusivity incentives—have had profound implications for the legal strategies employed by both generic and brand-name companies.

In this 90-minute audio conference CD, expert attorney Jay Sitlani will provide an in-depth analysis of how recent legislative, regulatory and judicial developments have affected brand and generic regulatory and litigation strategies.

Click here for more information on the audio conference CD; or click here to order or call 1-800-688-2421 (1-404-262-5474) to order the CD recording (MP3 format). Please mention priority code 11T09564-7309.

REMS: Prepare for and Minimize the Impact of the FDA's Powerful New Regulatory Tool

On March 3, 2009 CDER met with 16 makers of long-acting opioid drugs to discuss a sweeping new Risk Evaluation and Mitigation Strategy (REMS) for these extended-release pain killers.

The FDA has already approved REMS for 14 drugs—from antibodies to asthma medications—and was seeking REMS on at least a dozen more even before the March meeting.

And don't expect the administration to compromise much if your drug ends up in the REMS crosshairs. As the FDA's Dr. Bob Rappaport wrote, "We expect all companies marketing these products to work with us to get this done expeditiously. If not, we cannot guarantee that these products will remain on the market."

So are you ready to play ball with the FDA? In this 90-minute audio conference CD, REMS expert attorney Arnold Friede will tell you how we got here, where we are going, and how to prepare for and manage the risk if your product makes the REMS hit parade.

Click here for more information on the audio conference CD; or click here to order online or call 1-800-688-2421 (1-404-262-5474) to order the CD recording (MP3 format). Please mention priority code 11T09561-7291.

Clinical Trial Agreement Indemnification Clauses: Protect Your Interests, Get Approval

Indemnification is often the most controversial issue in clinical trial negotiations and rightly so. If something goes wrong during a clinical trial, a lawsuit is almost sure to follow, and you could be on the hook for millions of dollars if the indemnification language is not worded in your favor.

Of course, your partners on the other side of the table know this, as well. Do you know what it takes to safeguard your interests, and to get their agreement?

In this 90-minute audio conference, attorney J. Michael Slocum will show how to negotiate these challenging clauses. He will describe the core aspects of indemnification analysis, and will showcase real-life language you can include in your CTAs that will cover you, and be acceptable to all involved.

Click here for more information on the audio conference CD; or click here to order online or call 1-800-688-2421 (1-404-262-5474) to order the CD recording (MP3 format). Please mention priority code 11T09565-7315.

CME and Off-Label Promotion: Find and Fix Noncompliance Before the Feds Do

The line between legitimate continuing medical education (CME) and illegal off-label promotion of a drug or device can be a fine one. Sales and marketing staff, often with proper intentions, can place their companies on the wrong side of the law. And the DOJ, FDA, HHS and others will come after compliance officers and executives who may have no knowledge of such misconduct.

Be prepared. In this 90-minute audio conference CD, attorney Elizabeth Gobeil and former federal prosecutor Holly Pierson will detail the rules of CME and promotion. Through case studies, they'll examine what constitutes legitimate education, and identify the red flags that investigators are looking for. They'll also describe recent enforcement activities with an eye toward governmental priorities for the future.

Click here for more information on the audio conference CD; or click here to order online or call 1-800-688-2421 (1-404-262-5474) to order the CD recording (MP3 format). Please mention priority code 11T09566-7321.

Is the FDA asking too much of your 510(k)?

By August 7, 2009, makers of 25 types of pre-1976 devices, and 510(k) devices of "substantial equivalence" to them, must submit new safety and efficacy data to the FDA. The agency will review the data, and may require already cleared devices to go through the PMA process. Failure to submit the required information will mean the device is now misbranded, and the FDA will initiate enforcement action.

Even before this, the FDA has been asking for more and more evidence for clearance sometimes more than that to which it is entitled under the substantial equivalence standard.

In this 90-minute audio conference CD, device submissions expert Mark DuVal will discuss what FDA is asking for in 510(k) submissions, and how you can effectively respond to FDA's ever increasing demands for more medical and scientific information.

Click here for more information on the audio conference; or click here to order the CD online or call 1-800-688-2421 (1-404-262-5474) to order the CD recording (MP3 format). Please mention priority code 11T09567-7327.

Comparative Effectiveness: Risks and Opportunities in the New Reimbursement Landscape

$1.1 billion has been allocated in the 2009 stimulus bill for comparative effectiveness research. CMS is in the first stages of a plan to make national coverage determinations based on "outcomes" evidence from competing treatments.

Now that comparative effectiveness is no longer a question of if or when, you must answer how you will meet the challenge. In this 90-minute audio conference, expert attorney Bernadette M. Broccolo will provide insight on reimbursement strategies in this new environment, and on the benefits the stimulus can provide to smart companies in research, health IT and more.

Click here for more information on the audio conference CD; or click here to sign up online or call 1-800-688-2421 (1-404-262-5474) to ask about a CD of the event. Please mention priority code 11T09568-7333.

FDA Unapproved Drug Initiative—Determine, Prove and Ensure Compliance

On March 30, 2009, the FDA fired its latest salvo against marketed unapproved drugs, giving nine companies 90 days to stop shipping certain narcotics.

These are not "fly by night" companies: Boehringer Ingelheim Roxane, Mallincrkodt Inc, and other pharmaceutical companies have been swept up in the FDA's Unapproved Drug Initiative. Due to complex rules on drug approvals and exemptions from decades past, companies may believe they are lawfully marketing some unapproved drugs, only to be slapped with a Warning Letter threatening "enforcement action."

Adding to the confusion, just 10 days after its latest round of Warning Letters on marketed unapproved drugs, the FDA changed course. The agency acknowledged that one type of drug on the list is "medically necessary," and allowed it to remain on the market until a replacement could be found.

So how can you navigate the confusing and shifting waters of the FDA's Unapproved Drug Initiative? In this 90-minute audio conference CD, Hyman, Phelps & McNamara attorney Kurt R. Karst will describe what a company can do to avoid being swept up in the FDA Unapproved Drug Initiative, and what to do if it currently is marketing an unapproved drug. Mr. Karst will also discuss how companies can bring their products into compliance.

Click here for more information on the audio conference; or click here to sign up online or call 1-800-688-2421 (1-404-262-5474) to sign up or ask about a CD of the event. Please mention priority code 11T09570_7345.

Stem Cell Therapies: How to Benefit from New NIH Rules and Funding

Scientists rejoiced on March 9, 2009, when President Obama lifted the ban on federal funding for stem cell research. But the reality of getting stem cell studies underway is not so simple.

If the final NIH guidelines, to be released in July, are similar to the draft released in April, the new rules could be even more restrictive than those under the prior administration. Likewise, a law passed 14 years ago and still on the books prevents federal funding for many forms of stem cell research.

Click here for more information on the audio conference; or click here to order online or call 1-800-688-2421 (1-404-262-5474) to order the CD recording (MP3 format). Please mention priority code 11T09571-7351.

Online Advertising: Ensuring Compliance as DDMAC Steps Up Enforcement

On May 12, 2009, DDMAC issued a warning letter to Johnson & Johnson for a webcast video. Six weeks before, DDMAC sent untitled letters to 14 companies for defective online promotion of 46 different drugs and biologics.

With the FDA clearly examining your internet marketing, how can you be sure your efforts will not welcome DDMAC scrutiny? In this 90-minute audio conference CD, attorney Alan Minsk will provide recommendations to minimize risk of noncompliance in your communications through search engines and social media.

Click here for more information on the audio conference; or click here to order online or call 1-800-688-2421 (1-404-262-5474) to order the CD recording (MP3 format). Please mention priority code 11T09572-7357.

Reporting Results and Adverse Events on clinicaltrials.gov

You know that you must register your studies on clinicaltrials.gov. But you must do more than just provide the details at the start of a trial you must also include the results of your study, including adverse events and numerous other data elements, no later than 12 months after the study's intended or actual completion date (whichever comes first).

In this 90-minute BioWorld Today audio conference CD, Mark Barnes will explore the new results and adverse events reporting requirements of clinicaltrials.gov, and how these requirements are being applied by the FDA and NIH. He will provide concrete examples of problems with results reporting and address the best practices in applying the requirements to your own trials, so that you and your staff can comply with these complex new rules.

Click here for more information on the audio conference; or click here to order online or call 1-800-688-2421 (1-404-262-5474) to order the CD recording (MP3 format). Please mention priority code 11T09574-7375.

How to Prevent (or Remove) an Integrity Hold

Think integrity holds only happen to scam artists and fly-by-night companies? Think again.

In February 2009, the FDA invoked its Application Integrity Policy (AIP) against a 48-year-old pharmaceutical manufacturer that made more than $1.6 billion last year. The company is now barred from selling 30 drugs in the United States, and has enlisted outside help to implement CAPA. If history is any guide, it could be at least a year before the AIP is lifted.

Click here for more information on the audio conference CD; or click here to order online or call 1-800-688-2421 (1-404-262-5474) to order the CD recording (MP3 format). Please mention priority code 11T09573-7369.

FDA Banning DESI Drugs—Submissions Strategies to Keep Yours on the Market

Makers of DESI drugs face an uncertain future. Since 2006, the FDA has removed these drugs, some on the market for decades, through its Unapproved Drug Initiative. Often the only notice companies receive is a warning letter demanding they stop shipping the DESI drug in 90 days or less, or face "enforcement action."

Companies need not give up on a product that provides profits and helps consumers, however. DESI drugs can be, and have already been, approved via the 505(b)(2) pathway—a faster and less expensive option than a traditional NDA. Companies may even be able to block their competitors with 5 years of market exclusivity—if they understand the process.

In this 90-minute interactive audio conference CD, Ken Phelps, President of Camargo Pharmaceutical Service, will show how your DESI drugs can stay on the market, legally, and with the benefits that FDA approval provides. Or, for those who are trying to fill their product pipeline quickly, Ken will discuss how the 505(b)(2) pathway can give new life to effective but forgotten pharmaceuticals.

Click here for more information on the audio conference; or click here to order online or call 1-800-688-2421 (1-404-262-5474) to order the CD recording (MP3 format). Please mention priority code 11T09575-7382.

GMP Training Documentation: Steps to Prove Compliance

The FDA has made clear that, for drugs and devices, GMP training must be documented:

"Each manufacturer shall establish procedures for identifying training needs ... Training shall be documented."
21 CFR 820.25

"Managers are expected to establish training programs that include ... documentation of training and/or re-training."
Guidance for Industry Quality Systems Approach to Pharmaceutical CGMP Regulations

Sounds simple enough. And yet, warning letters continue to cite GMP training documentation violations, such as this letter from September 2008:

"failed to comply with Section 1.4.1 of its training procedure to implement and document new hire training activities for employees engaged in the production of drug products."

And this from May 2009:

"You do not have records documenting your employee has the necessary education, background, training, or experience."

Find out if your training documentation is in compliance, and what you need to do to get and keep it there. In this 90-minute audio conference, GMP expert attorney Cathy Burgess will describe what good and bad documentation looks like, and will provide steps companies can take to get their training records into line before their next inspection.

Click here for more information on the audio conference; or click here to order online or call 1-800-688-2421 (1-404-262-5474) to order the CD recording (MP3 format). Please mention priority code 11T09576-7383.

Unannounced FDA Raids: Be Ready Before They Appear at Your Door

The FDA is outside your door—but this isn't a typical inspection. Instead of a Form 482, the criminal investigator is holding a search warrant. And for the rest of the day, she and her team will be removing stacks of documents, copying dozens of hard drives, and interviewing as many of your employees as possible, without your legal counsel being present.

Hopefully, this won't be how today ends for you. But this does happen with increasing frequency at FDA regulated companies—and by that time, it is often too late. Regardless of your compliance efforts during a regulatory inspection or how you handled the last warning letter, your company should have a plan in place to manage an unannounced criminal raid.

In this 90-minute audio conference, attorneys John Fleder and William Koustas will explain how the search warrant process works and provide guidance on creating a plan for search warrant raids by the FDA or other government agencies.

Click here for more information on the audio conference; or click here to order online or call 1-800-688-2421 (1-404-262-5474) to order the CD recording (MP3 format). Please mention priority code 11T09577-7389.

Ensure Your Study Stays Safe; Your IRB is Compliant

Is your IRB in compliance? Are you sure?

In June 2009, 300 protocols and 3,000 sites were adversely impacted when, through no fault of the sponsor or site, their IRB was shut down by the FDA.

Now is the time to ensure that your IRB is in complete compliance. In this all new BioWorld Today audio conference CD, former FDA BiMo investigator Carl Anderson will give you the insight you need to keep your protocols up and running.

Click here for more information on the audio conference CD; or click here to order online or call 1-800-688-2421 (1-404-262-5474) to order the CD recording (MP3 format). Please mention priority code 11T09578-8331.

Medicare Coverage Analysis: Conduct the Correct One for Your Trial

Conducting a Medicare coverage analysis (MCA) is required for accurate and compliant billing of medical services provided in a clinical trial. Likewise, an MCA provides information essential for sponsors and sites conducting clinical trial agreement negotiations.

So how do you know you're doing it right? In this 90 minute audio conference CD, clinical trials expert Mark Barnes will provide insight on the rules and process of conducting an MCA. He'll show the mistakes that are often made and how to ensure you don't do the same. He will also address the related issue of charging for drugs made available through expanded access protocols under the new FDA rules issued on August 12, 2009.

Click here for more information on the audio conference CD; or click here to order online or call 1-800-688-2421 (1-404-262-5474) to order the CD recording (MP3 format). Please mention priority code 11T09579-8337.

Pre-IND Meeting Success: Know and Remove Roadblocks to Trial Approval

Soon after your Pre-IND meeting with the FDA, you will know if your trial can move forward—but what you do before and during that meeting will determine its fate.

Are you ready to defend your treatment's safety and viability before a single patient has received it? Can you answer all the FDA's concerns in less than an hour?

If you aren't 100% sure, this audio conference CD can help you get there. In 90 minutes, expert consultant Betty Holland will show you how to prepare for your pre-IND meeting, what surprises the FDA might have in store, what data to have at the ready when they ask questions and the questions you should be asking them. Although valuable for anyone who has a pre-IND meeting planned with the FDA, this audio conference is a must for professionals facing their first pre-IND consultation.

Click here for more information on the audio conference; or click here to order the CD online or call 1-800-688-2421 (1-404-262-5474) to order the CD recording (MP3 format). Please mention priority code 11T09581-8349.

15 Days Until Enforcement: Responding to 483s and Warning Letters from the New FDA

Your company has just been issued a 483. When you respond, and what you say in your response, can reduce the risk of a warning letter.

Or perhaps your company's response to a 483 wasn't satisfactory to the FDA, and now you do have a warning letter. What now?

In the past, perhaps not much, It may have been months or years before the FDA issued another warning letter, followed by another warning letter, before any kind of action was taken.

Not anymore. Starting September 15, companies that receive a 483 may have only 15 days to respond and correct issues before a Warning Letter is issued and/or other enforcement actions are taken. Additionally, Warning Letters will now be reviewed by the Office of Chief Counsel only when they "present significant legal issues".

These changes mean that 483s will lead to Warning Letters much faster, and that Warning Letters will carry more weight. But there is an upside: companies that get it right, and fix the problems cited, could receive a "close-out letter"—essentially a clean bill of health from the FDA.

So how do you ensure that you are responding to 483s and Warning Letters quickly and correctly? In this 90-minute audio conference CD, former FDA deputy associate commissioner for Regulatory Operations Steve Niedelman and attorney Cathy Burgess will discuss what you must do, from the time the investigator signs her name until the FDA indicates "no further action is necessary."

Click here for more information on the audio conference; or click here to order the CD online or call 1-800-688-2421 (1-404-262-5474) to order the CD recording (MP3 format). Please mention priority code 11T09582-8355.

Regulatory Submissions Data System Integration: How Amgen Did It, How You Can Do It

Can you have one system managing all your regulatory submissions data, across all layers and divisions of your organization? What would it mean to you, your team, and your company to handle all the information pertaining to submissions, on paper and electronic, through a single interface that everyone can access, no matter where they are, at the level at which they are approved?

Sounds like a pipe dream, or a pie in the sky pitch from a vendor wanting a multi-million dollar sale. But this is exactly what was done at Amgen. And in this 90-minute audio conference CD, its Director of Global Regulatory Affairs and Safety, Matthew Neal, will explain how Amgen did it. He'll describe the roadblocks they faced, the challenges in getting buy-in and implementation, and the payoff: sending two submissions to the FDA on the first day of operation.

Click here for more information on the audio conference; or click here to order the CD online or call 1-800-688-2421 (1-404-262-5474) to order the CD recording (MP3 format). Please mention priority code 11T09580-8343.

Adverse Event Reporting: Prove Compliance as Enforcement Increases

Adverse Events (AE) happen multiple times in nearly every clinical trial. How you deal with them is what matters. But just how you report them, and to whom you report them, can be confusing.

Is it a Serious AE? Is it also an Unanticipated Problem? Are you subject only to FDA regulations? Common Rule? NIH requirements? IRB demands?

How do you document and file? How do you prove you did everything right?

Answer these questions wrong, and you could face FDA warning letters, have your trials stopped, or your product denied approval. And given the FDA's new focus on enforcement and follow-up, it is more important than ever to make sure you are reporting correctly.

In this 90-minute audio conference CD, clinical trials expert Mark Barnes will detail the AE reporting process what to report, what not to report, and how, when, and to whom reports should be made. He'll tell you what the regulations and guidances don't, to show how to document and prove compliance, and to ensure patient safety.

Click here for more information on the audio conference; or click here to order the CD online or call 1-800-688-2421 (1-404-262-5474) to order the CD recording (MP3 format). Please mention priority code 11T09583-8361.

Investigational Device Exemptions Made Easy

Your company has just been issued a 483. When you respond, and what you say in your response, can reduce the risk of a warning letter.

Or perhaps your company's response to a 483 wasn't satisfactory to the FDA, and now you do have a warning letter. What now?

Any device of "significant risk" must receive an Investigational Device Exemption (IDE) before clinical trials can proceed.

Sounds straightforward enough. But, as many Class II devices subject to 510(k) are increasingly expected to gain an IDE, and as Congress and the FDA increase their scrutiny of the data required for approval, device companies will need to be intimately familiar with the IDE process.

In this 90-minute audio conference CD, device expert Karen Bannick will describe the ins and outs of regulations you must follow when preparing an IDE submission to the FDA. She will also go beyond the published rules and show how to make the submission easier for FDA to review, and more likely to be approved without unnecessary delays.

Click here for more information on the audio conference; or click here to order online or call 1-800-688-2421 (1-404-262-5474) to order the CD recording (MP3 format). Please mention priority code 11T09584-8367.

CAPA: Get it Right the First Time

Will your CAPA find and fix problems right, the first time?

For many companies, the answer, unfortunately, is "no." Despite taking the recommended corrective action, repeat investigations are required an estimated 30% of the time.

And the New FDA won't wait the Administration will soon issue Warning Letters just 15 days after a 483 finding, and will send most of them from their field offices. This means your CAPA must be on point, or you could face swift and severe enforcement.

But, if your CAPA fixes the problems, the FDA plans to issue a "close out letter" announcing to the public that all is well.

Ensure your CAPA program gets it right on the first try. In this all new Medical Device Daily audio conference, CAPA expert Nathan Conover will examine why repeat investigations happen, and offers tips and techniques to overcome them.

Click here for more information on the audio conference; or click here to order online or call 1-800-688-2421 (1-404-262-5474) to order the CD recording (MP3 format). Please mention priority code 11T09585-8373.

Promotion at Trade Shows and Medical Meetings: Not If, but How

The promotion of prescription drugs and devices at trade shows and medical meetings is a critical component of marketing success, but questions of regulatory gray areas arise frequently. Well intentioned or not, a misstep in developing your promotions in these forums can lead to major compliance and legal problems. And with the FDA now on enforcement footing, you need now, more than ever, to be sure your efforts are legal.

In this 90 minute audio conference, attorney William Kitchens will explain what legitimate promotional activity in these forums is, and provide guidance on structuring your promotions to avoid regulatory headaches.

Click here for more information on the audio conference; or click here to order online or call 1-800-688-2421 (1-404-262-5474) to order the CD recording (MP3 format). Please mention priority code 11T09586-8379.

Off-Label Promotion: Be Careful, Be Very Careful

It's a good question to ask, after a $2.3 billion settlement by Pfizer in September, and a $1.4 billion settlement earlier this year by Eli Lilly.

Your detailers aren't attorneys, so they won't always know what is legal, especially in an area confusing as off-label promotion law.

To help them, in this 90 minute audio conference presentation, attorney Alan Minsk will describe the common pitfalls of interacting with healthcare professionals, and show what is, and what is not, acceptable communication. He will also provide you with insight on structuring your compliance program to reduce risk, and empowering your staff to do what they do best—educate providers about your product.

Click here for more information on the audio conference; or click here to order online or call 1-800-688-2421 (1-404-262-5474) to order the CD recording (MP3 format). Please mention priority code 11T09588-10047.

Trial Master File: Ensure Your Trial Documentation Will Pass FDA Inspection

Your clinical trial has zero chance of passing an FDA inspection or QA audit if your Trial Master File (TMF) is not in order.

The FDA frequently states that if compliance isn't documented, it didn't happen. Your TMF serves as living proof that you are adhering to GCP, and that your quality system is in a state of control.

Beyond simply being a get out of jail free card, a well-maintained TMF can make trial management easier; with a typical TMF containing thousands of pages of documentation, you could easily save, or lose, hundreds of hours over the life of a trial searching for individual pieces of knowledge.

In this 90-minute audio conference, clinical trials expert Carl Anderson will provide guidance on the TMF. He'll describe the steps to take throughout a trial to ensure your TMF will pass inspection by FDA investigators and QA auditors. He'll also highlight, through real-world examples, some of the pitfalls and pressure points you can expect as you build your TMF.

Click here for more information on the audio conference; or click here to order online or call 1-800-688-2421 (1-404-262-5474) to order the CD recording (MP3 format). Please mention priority code 11T09589-10053.

BLAs: Get Approved in the First Review Cycle

What will happen if your Biologics License Application (BLA) is not approved?

On June 30, 2008, Introgen Therapeutics submits a BLA for Advexin. Two months later, the FDA responds with an RTF. In November, "nearly all" Introgen senior management resigns. Days later, the company is delisted from NASDAQ and begins liquidation.

Hopefully, your company will not crash due to one failed BLA. But, the time and money lost can be difficult for any company, especially in the current economic and regulatory environment.

In this 90 minute audio conference, former FDA insider Joyce Frey-Vasconcells, PhD, will show you what it takes to get your BLA approved in the first review cycle.

Click here for more information on the audio conference; or click here to order online or call 1-800-688-2421 (1-404-262-5474) to order the CD recording (MP3 format). Please mention priority code 11T09590-10073.

Quality System Audits: What You Must Do to Prove Compliance

26 warning letters were issued in the last 12 months for failures in the audit and documentation of quality system (QS) more than a third of all the QS warning letters issued. Now, with the FDA stepping up enforcement, and turning 483s into warning letters faster than ever, you must be sure your audit procedures and documentation will pass inspector scrutiny.

In this all new Medical Device Daily audio conference, QS expert Pamela Sculthorp will provide the processes to effectively expedite and document investigations for their organization.

Click here for more information on the audio conference; or click here to order online or call 1-800-688-2421 (1-404-262-5474) to order the CD recording (MP3 format). Please mention priority code 11T09587-8385.

De Novo 510(k): Strategies for Successful Class III Appeals

The FDA now says it made mistakes in clearing Menaflex under a 510(k), and that it will address "multiple weaknesses" in the 510(k) process.

Translation: What qualifies, in practice, as a "predicate device" will likely change and it will not make your job easier. The amount of data required, especially clinical data, will be greater and more expensive. But, just because you receive a Not Substantially Equivalent (NSE) finding, that may not mean that a PMA is your only option.

The de novo 510(k) provides a pathway for devices that are safer than Class III, but do not have a predicate. But you must move fast you have only 30 days from the NSE to request a de novo reclassification. And, for the FDA to concur, it takes more than a nicely worded letter.

So what does it take? In this 90 minute audio conference, device expert Mark DuVal will describe the ins and outs of the de novo 510(k) process, and share, through his own experiences, what the FDA needs to see to reclassify a device. He'll also examine the changing approvals climate, and show how companies should manage the risk of increased NSEs.

Click here for more information on the audio conference; or click here to order online or call 1-800-688-2421 (1-404-262-5474) to order the CD recording (MP3 format). Please mention priority code 11T09591-10086.

FDA and Web 2.0: What the Public Hearings Will Mean for your Online Marketing Efforts

On November 12 and 13, the FDA held public hearings on using social media and Web 2.0 in promoting FDA-regulated products.

So now, the Agency is ready to tell companies how they should disclose risk in tweets, who responds to incorrect statements on YouTube, and how to disclose involvement in Wikipedia posts, right?

In this 45 minute audio briefing, attorney Alan Minsk will discuss the results of these two days of meetings, as well as FDA's position and enforcement in this area, and describe how they should factor into your online promotion compliance strategy.

So what does it all mean to you? In this 45 minute audio briefing, attorney Alan Minsk will discuss the results of these two days of meetings, as well as FDA's position and enforcement in this area, and describe how they should factor into your online promotion compliance strategy.

Click here for more information on the audio conference; or click here to order online or call 1-800-688-2421 (1-404-262-5474) to order the CD recording (MP3 format). Please mention priority code 11T09592-10134.

Root Cause Analysis Failures on the Rise: Be Sure You're Compliant

The FDA is keeping its promise to increase enforcement.

In just the last six months, 27 Warning Letters cite Root Cause Analysis (RCA) defects more than in any other six month period of the last 8 years! And, with 483s turning into Warning Letters in just 15 days, having an effective RCA ready to go, immediately, is essential to your CAPA's success.

Be ready. In this 90 minute audio conference, RCA expert Nathan Conover will provide the tools your team needs to initiate and complete an RCA that gets answers.

Click here for more information on the audio conference; or click here to order online or call 1-800-688-2421 (1-404-262-5474) to order the CD recording (MP3 format). Please mention priority code 11T09593-10164.

International Clinical Trials: Contracts, Costs, and How to Protect Your Interests

In 2007, one third of trials sponsored by the top 20 pharma companies were conducted entirely outside of the United States.

Since 2002, the number of active FDA–regulated investigators outside the U.S. has grown 15% each year—domestically, they ve declined 5.5%

From 2006 to 2008, clinical trials conducted in India doubled.

However you look at it, international clinical trials are on the rise. This means clinical trial agreements, intellectual property rights, staffing issues and more—normally a challenge in U.S.-only trials—become even more complicated.

As the number of legal jurisdictions regulating your work doubles and triples, how can you be sure you are protecting your interests? In this 90 minute audio conference, contracts expert J. Michael Slocum will provide insight and solutions to the biggest challenges of international clinical trial conduct and contracting.

Click here for more information on the audio conference; or click here to order online or call 1-800-688-2421 (1-404-262-5474) to order the CD recording (MP3 format). Please mention priority code 11T09594-10236.

Responsibilities of the Clinical Investigator: What You Must Do to Ensure Trial Compliance

No clinical investigator wants his or her reputation to be harmed; certainly, no one wants to invite negative attention from the FDA. Yet, 25 investigators received warning letters from the FDA in the last 12 months.

Why?

Perhaps because there are so many procedures and paperwork requirements mandated by the FDA. Or maybe, since much of the work is done by research associates and other team members, it is difficult to ensure everyone is trained and working within the rules.

Regardless, the FDA expects 100% compliance of those conducting trials. So how do you get there? In this 90 minute audio conference, clinical trials expert Cheri Wilczek will provide real-world guidance to investigators so they can ensure and prove compliance.

Click here for more information on the audio conference; or click here to order online or call 1-800-688-2421 (1-404-262-5474) to order the CD recording (MP3 format). Please mention priority code 19T10595-10280.

Informed Consent: 8 Unique Ways to Ensure Compliance, Improve Patient Care

From three recent FDA warning letters issued for informed consent violations:

Your response is inadequate in that although you have amended the informed consent to include the missing elements, there is no evidence that subjects were re-consented with the amended informed consent form.

Dr. [redacted] letter of June 12, 2008, indicates that a signed informed consent document was obtained from subject... However, according to Dr. [redacted] the signed informed consent form for this subject was lost.

Even though FDA would consider this to be a non-significant risk device, because you... failed to ensure informed consent was obtained from each subject under 21 CFR part 50 you were not considered to have an approved application for an IDE.

28 warning letters have been issued in the last 12 months to sponsors, investigators, and IRBs for informed consent problems. Despite clear language from the FDA on what proper consent is, and additional guidance from the Agency and ICH, violations still occur.

Click here for more information on the audio conference; or click here to order online or call 1-800-688-2421 (1-404-262-5474) to order the CD recording (MP3 format). Please mention priority code 19T10597-10369.

505(b)(2) Candidate Selection: Strategies for Finding Your Next Profit Center

With drug pipelines drying up, the 505(b)(2) pathway provides a way to bring millions in revenue from previously discovered pharmaceuticals. But not all drugs are good candidates.

So how do you find the right drug? In this 90 minute audio conference, Ken Phelps will discuss your 505(b)(2) options, and show the kinds of chemical entities that can gain approval, and bring a profit, efficiently—and which will cause more trouble than they are worth.

Click here for more information on the audio conference; or click here to order online or call 1-800-688-2421 (1-404-262-5474) to order the CD recording (MP3 format). Please mention priority code 19T10598-10396.

Understanding Adverse Event Reporting for Investigational Medical Devices

Adverse event reporting is a major compliance concern for sponsors and research sites conducting medical device trials. Unfortunately, unclear definitions and different requirements for what is reported, to whom, and when only adds to the confusion.

Be sure you are in compliance; in this 90 minute audio conference, clinical trials expert Douglas Albrecht will provide a thorough overview of reporting adverse events in device clinical trials. He will define confusing terminology in the regulations, and describe the challenges in understanding when events are reportable as adverse events and when they are not.

Click here for more information on the audio conference; or click here to order online or call 1-800-688-2421 (1-404-262-5474) to order the CD recording (MP3 format). Please mention priority code 19T10599-10458.

Device Complaint Handling: Solving Your Toughest Reporting Problems

38 Warning Letters citing deficient complaint handling were issued during the last 12 months to medical device manufacturers large and small. And, with the FDA's increased focus on enforcement, you can be sure compliance with 820.198 will be scrutinized now more than ever, since the Agency considers complaint handling to be a harbinger of overall quality system integrity.

In this 90 minute audio conference, medical device expert Judith Andrews, Ph.D. will address the essential elements for maintaining an effective and compliant complaint handling system.

Click here for more information on the audio conference; or click here to order online or call 1-800-688-2421 (1-404-262-5474) to order the CD recording (MP3 format). Please mention priority code 19T10600-10507.

Trial Site Insight: Ensure your Trial Master File Will Pass FDA Inspection

In 2009, CDER sent 18 warning letters to trial sites for GCP violations—up from only 5 just three years before. And, with the FDA on enforcement footing, this number is likely to increase.

In this 90 minute audio conference, former FDA BiMo inspector Carl Anderson will, through real-world case studies and FDA Warning Letter citations, provide practical solutions for clinical sites to maintain an effective, compliant TMF. He will also answer your site-specific TMF questions in the Q&A session.

Click here for more information on the audio conference; or click here to order online or call 1-800-688-2421 (1-404-262-5474) to order the CD recording (MP3 format). Please mention priority code 19T10601-10595.

Auditing Suppliers and Contractors: Be Ready for Increased FDA Scrutiny

FDA regulations are clear whether for drugs or devices, you are responsible for the quality of your product, regardless of what areas of your operation you outsource, or who actually made your product. And, with the New FDA focused on enforcement, you must ensure that your suppliers are manufacturing product to the same high standards you would.

In this 90-minute audio conference, former FDA credentialed inspector Dennis Moore will show how to ensure your outsourced suppliers will follow FDA regulations. You'll learn what the FDA is looking for, and how things may change with the many recent supply chain safety failures.

Click here for more information on the audio conference; or click here to order online or call 1-800-688-2421 (1-404-262-5474) to order the CD recording (MP3 format). Please mention priority code 19T10602-10653.

Drug Recalls: Effective Planning for the Inevitable

Hundreds of drugs are recalled every year. How you handle a recall, from dealing with the FDA, to communicating with patients and doctors, to logistics of product return and credit, to mitigating legal risk, is what matters. And in this global economy it is critical that a recall be coordinated on a world wide basis. A single misstep can cost billions in revenue and expenses, the trust of your customers, and hundreds of jobs—perhaps even your own.

To do it right, you need a plan. And in this 90 minute audio conference, expert attorney James M. Wood will describe how to proactively plan for recalls—who should be on the recall team, the right strategy for communication with stakeholders, and how to protect your company while ensuring patient safety. He will also examine the Gold Standard for drug recalls—the 1982 Johnson & Johnson recall of Tylenol—and show how the lessons of that case apply to your recall plan today.

Click here for more information on the audio conference; or click here to order online or call 1-800-688-2421 (1-404-262-5474) to order the CD recording (MP3 format). Please mention priority code 19T10603-10729.

Off-label Promotion vs. Scientific Exchange: Ensure Effective and Compliant Medical Affairs Communication

Medical Science Liaisons (MSLs) are legally empowered to engage in scientific exchange with prescribers. They are NOT allowed to promote off-label uses for prescription drugs or medical devices.

A simple concept, but ensuring, in practice, this line is not crossed is far from easy. And, when that line is blurry, do you insist on compliance at all costs, or do you lean toward getting product information out? Do you have a policy that addresses every contingency, or do you make case by case judgment calls? Or do you just look the other way and hope everything works out?

Gain clarity on this important area of your business. In this 90 minute audio conference, former FDA Regulatory Counsel Richard Lev, and MSL expert Robin Winter-Sperry. MD will provide strategies on how to ensure effective scientific exchange and education, while maintaining off-label compliance.

Click here for more information on the audio conference; or click here to order online or call 1-800-688-2421 (1-404-262-5474) to order the CD recording (MP3 format). Please mention priority code 19T10604-10735.

EMEA vs. FDA Clinical Trial and Pharmacovigilance Regulations: Ensure Compliance with Both

For decades FDA was known as the "Gold Standard" for regulatory oversight of clinical trials. In 2005, updates to the 2001 Clinical Trials Directive became effective in the European Union and researchers faced a new way of regulating clinical trials. The same became true of post-market safety reporting as FDA and EMEA took divergent paths. Sponsors and clinical sites started grappling with how to be compliant with both FDA and EMEA.

In this 90-minute audio conference former FDA BiMo Inspector Carl Anderson will examine the requirements of both agencies and show their similarities and differences. He will also offer practical solutions to compliance with a changing clinical trial and pharmacovigilance landscape.

Click here for more information on the audio conference; or click here to order online or call 1-800-688-2421 (1-404-262-5474) to order the CD recording (MP3 format). Please mention priority code 19T10606-10755.

Clinical Trial SOPs: Ensure Your Procedures are Compliant and Followed Correctly

Clinical regulations are open to interpretation. When you or your research staff have questions about how, in practice, to ensure compliance, your company's SOPs should have the answer.

But do they? And when the FDA investigator reviews them, will she agree? In this 90 minute audio conference, former FDA investigator Bernadette Ott will provide strategies on writing, reviewing, and enforcing clinical SOPs, for both compliance and usability.

Click here for more information on the audio conference; or click here to order online or call 1-800-688-2421 (1-404-262-5474) to order the CD recording (MP3 format). Please mention priority code 19T10605-10748.

Quality Management System Audits: Achieve Compliance, Efficiency, and Bottom Line Improvement

64 warning letters have been issued since January 2008 for noncompliance with CFR 820.22 quality system audits. This, despite the tremendous scrutiny FDA investigators pay to internal audit procedures, and the importance of QS audits to the health of products that go out the door.

Good QS audits can find and fix problems that cause defects, product recalls, and liability suits. Inefficiencies can be discovered, creating opportunities to reduce costs and waste.

On this 90-minute audio conference CD, QS expert Susan Reilly will show how to develop audits that prove compliance, increase efficiency, and drive bottom line improvement. She ll describe how to organize and coordinate audits, from initial planning to team selection, to execution and documentation, and through analysis and planning for the next audit.

Click here for more information on the audio conference; or click here to order online or call 1-800-688-2421 (1-404-262-5474) to order the CD recording (MP3 format). Please mention priority code 18T10607-10828.

Clinical Trial Agreement Indemnification Clauses: Protect Your Interests, Get Approval

Indemnification is often the most controversial issue in clinical trial negotiations and rightly so. If something goes wrong during a clinical trial, a lawsuit is almost sure to follow, and you could be on the hook for millions of dollars if the indemnification language is not worded in your favor.

Of course, your partners on the other side of the table know this, as well. Do you know what it takes to safeguard your interests, and to get their agreement?

In this 90 minute audio conference, attorney J. Michael Slocum will show how to negotiate these challenging clauses. He will describe the core aspects of indemnification analysis, and will showcase real-life language you can include in your CTAs that will cover you, and be acceptable to all involved.

Click here for more information on the audio conference; or click here to order online or call 1-800-688-2421 (1-404-262-5474) to order the CD recording (MP3 format). Please mention priority code 19T10608-10848.

Navigating the Orphan Drug Designation Process, and the Benefits of Obtaining Designation — Audio Conference

December 1, 2009: Pfizer licenses a treatment for Gaucher's disease and gains orphan drug designation and fast track status.

October 13, 2009: GlaxoSmithKline licenses a drug for the rare Duchenne muscular dystrophy with plans to pursue orphan drug designation.

Though these deals made headlines, they were far from the first orphan drug activities: Indeed, more than 350 approved products have resulted from the Orphan Drug Program. And orphan drugs make good business sense, as they can provide 7 years of market exclusivity, tax credits and other advantages.

So how do you do it – and does it make sense for your product? In this 90 minute audio conference, attorney Kurt Karst will discuss the many benefits of obtaining orphan drug designation. He will also show how to obtain orphan drug designation, and how to avoid regulatory and other pitfalls along the way.

Click here for more information on the audio conference; or click here to order online or call 1-800-688-2421 (1-404-262-5474) to order the CD recording (MP3 format). Please mention priority code 19T10609-10856.

Reimbursement in 2010 and Beyond: Understand the Changing Legal Landscape — Audio Conference

December 1, 2009: Pfizer licenses a treatment for Gaucher's disease and gains orphan drug designation and fast track status.

The legal environment affecting drug and biologic commercial and Medicare rebate and discount practices in 2010 and beyond is changing. At the beginning of the decade, pharmaceutical and biotech companies are poised to experience continued and increased enforcement actions. At the same time, the government and many private payors are increasingly looking to those same industries to fund a larger portion of the health system bill. However, reconciling such health system buzz words of "outcomes-based reimbursement" and "comparative effectiveness" to the legal realities impacting the related discount contracting practices can be challenging.

In any investigation, one of the first things reviewed is the relevant "paper." Therefore, it is critical to understand better contracting practices to help your organization protect its business and legal rights. In this 90-minute audio conference, attorney Kathleen Peterson will review recent enforcement actions that may have implications for such contracts, as well as relevant legislative initiatives that may affect contracting strategies.

Click here for more information on the audio conference; or click here to order online or call 1-800-688-2421 (1-404-262-5474) to order the CD recording (MP3 format). Please mention priority code 19T10610-10933.

REMS: The Regulatory, Legal and Commercial Consequences of Risk Management for the Pharmaceutical and Biotech Industries—Audio Conference

The Food and Drug Administration Amendments Act of 2007 (FDAAA) provided the FDA with new and significant authority over every aspect of pharmaceutical industry activities in perhaps the most significant legislation since the Kefauver amendments in 1962. Nowhere is this authority more pronounced and far reaching than in the safety regulations of the Risk Evaluation and Mitigation Strategies commonly referred to as "REMS." These regulations allow the FDA to exert direct authority over nearly every aspect of pharmaceutical development and commercialization, with resulting ramifications on clinical trial development, marketing, advertising, and product liability exposure, to name only a few.

The interactive audio conference will provide an in depth review of the REMS litigation as well as the Draft Guidance recently issued by the FDA. Further, the conference will analyze the REMS program to date and the practical implications for every company with active research and development programs as well as products on the market.

Click here for more information on the audio conference; or click here to order online or call 1-800-688-2421 (1-404-262-5474) to order the CD recording (MP3 format). Please mention priority code 19T10611-11202.

Documenting and Conducting Out of Specification (OOS) Investigations—Audio Conference

In an FDA regulated environment, accurate and thorough investigation is a critical response for out of specification (OOS) laboratory test results. The challenge is to capture necessary information in a timely fashion from a diverse workforce of individuals with technical and non-technical backgrounds.

In this 90-minute audio conference, expert Nathan Conover will provide a process to overcome that challenge, integrating FDA requirements and guidelines that focus on effective documentation, data collection, and the understandable language necessary for successful investigations.

Click here for more information on the audio conference; or click here to order online or call 1-800-688-2421 (1-404-262-5474) to order the CD recording (MP3 format). Please mention priority code 19T10612-11209.

Update! FDA and Web 2.0: What's Next from the FDA's Web 2.0 Public Hearings on Online Marketing—Audio Briefing

On November 12 and 13, 2009, the FDA held public hearings on using social media and "Web 2.0" in promoting FDA-regulated products.

So now, the Agency is ready to tell companies how they should disclose risk in tweets, who responds to incorrect statements on YouTube, and how to disclose involvement in Wikipedia posts, right?

In this 45 minute audio briefing, attorney Alan Minsk will discuss the results of these two days of meetings, as well as FDA's position and enforcement in this area and describe how they should factor into your online promotion compliance strategy.

Click here for more information on the audio conference; or click here to order online or call 1-800-688-2421 (1-404-262-5474) to order the CD recording (MP3 format). Please mention priority code 19T10613-11249.

Trial Master File: Ensure Your Trial Documentation Will Pass FDA Inspection — Audio Conference

Your clinical trial has zero chance of passing an FDA inspection or QA audit if your Trial Master File (TMF) is not in order.

The FDA frequently states that if compliance isn't documented, it didn't happen. Your TMF serves as living proof that you are adhering to GCP, and that your quality system is in a state of control.

Beyond simply being a get out of jail free card, a well-maintained TMF can make trial management easier; with a typical TMF containing thousands of pages of documentation, you could easily save, or lose, hundreds of hours over the life of a trial searching for individual pieces of knowledge.

In this 90-minute audio conference, clinical trials expert Carl Anderson will provide guidance on the TMF. He'll describe the steps to take throughout a trial to ensure your TMF will pass inspection by FDA investigators and QA auditors. He'll also highlight, through real-world examples, some of the pitfalls and pressure points you can expect as you build your TMF.

Click here for more information on the audio conference; or click here to order online or call 1-800-688-2421 (1-404-262-5474) to order the CD recording (MP3 format). Please mention priority code 19T10614-11376.

Root Cause Investigation for CAPA — Two Part Webinar Series — Audio Conference

You know that, unless you can get to the root cause of your problem, your CAPA will fail—and the FDA will know it, too.

So are you ready to roll up your sleeves, and learn how to conduct a successful root cause analysis once and for all?

In this special two part webinar series, process improvement expert Tom Weaver will present, using a detailed case study, his science-based, 7-step investigation methodology for finding and fixing root cause problems. This proven method integrates problem solving techniques from TQM, Six Sigma, and other problem solving approaches to identify both the technical root cause and any systemic root causes. He will show the corrective and preventive actions to be taken so that the performance can be restored to previous levels.

Get your entire team all the in-depth, need to know insight on conducting a root cause analysis. Develop solutions to specific issues you are facing in your RCA and learn techniques you need to successfully find and fix root cause problems.

Click here for more information on the audio conference; or click here to order online or call 1-800-688-2421 (1-404-262-5474) to order the CD recording (MP3 format). Please mention priority code 19T10615-11401.

Auditing Suppliers and Contractors: FDA's New Scrutiny of Imports — Audio Conference

FDA regulations are clear—whether for drugs or devices, you are responsible for the quality of your product, regardless of what areas of your operation you outsource, or where the product was made, including overseas. And, with the FDA's recent emphasis on enforcement at the borders for imports, you must ensure that your suppliers are manufacturing product to the same high standards you would. Import detention is a very costly FDA compliance hold to remove, and this webinar will help your company overcome the challenges!

In this 90-minute webinar, former FDA credentialed Investigator Dennis Moore will show how to ensure your outsourced suppliers will follow FDA regulations. You'll learn what the FDA is looking for, and how things may change with the many recent supply chain safety failures.

Click here for more information on the audio conference; or click here to order online or call 1-800-688-2421 (1-404-262-5474) to order the CD recording (MP3 format). Please mention priority code 19T10616-11492.

Biosimilars and Healthcare Legislation: How Recent Changes Open Up Opportunities

The recent Healthcare legislation contains provisions that will provide an eventual pathway for FDA-approval of generic biologics. But many questions remain, from access by the generics company to the biologics formula to what are the marketing dynamics that will shape the competitive landscape for follow-on biologics?

This 90-minute interactive audio conference will provide insight and understanding of how the recent healthcare legislation will affect the pathway for approved biosimilars, including a detailed explanation of the changes that must be made and how soon will this impact your business and regulatory activity.

Click here for more information on the audio conference; or click here to order online or call 1-800-688-2421 (1-404-262-5474) to order the CD recording (MP3 format). Please mention priority code 19T10617-11498.

Enforcement or Scientific Collaboration? The Brave New World of FDA Risk Assessment

"FDA will be prepared to act swiftly and aggressively to protect the public... If we find that we must move quickly to address significant health concerns or egregious violations, we will consider immediate action – even before we have issued a formal warning letter." FDA Commissioner Hamburg, August 6, 2009

"An approach of extremes puts the agency in the position of not commenting on science... A binary approach that cycles between what can be seen as false assurance and draconian enforcement can lead the public to doubt the quality of industry products." FDA Commissioner Hamburg, April 21, 2010

FDA's recent enforcement initiative, with post-inspection deadlines, accelerated issuance of warning letters and aggressive follow-up signaled a significant change in FDA's approach to regulatory violations. As a result of this initiative, the number of Warning Letters has more than doubled in the past year, with an average of x warning letters each month. Moreover, the number of seizures and injunctions is on the rise.

Click here for more information on the audio conference; or click here to order online or call 1-800-688-2421 (1-404-262-5474) to order the CD recording (MP3 format). Please mention priority code 19T10618-11557.

Clinical Trial Transparency Is 'Real' Work! An Update on Clinical Trial Registration and Results Disclosure Requirements

The FDA Amendments Act of 2007 (FDAAA) enacted in September 2007 instituted requirements for the public registration of clinical trials of drugs, biologics and medical devices and for posting of applicable clinical trials results online. FDAAA also left some significant questions unanswered; answers to these open questions are due later this year. The State of Maine overhauled their clinical trial disclosure law in November 2009. More than twenty countries have clinical trial disclosure expectations – some codified in law and others enforced by other mechanisms.

Study sponsors often react with a shake of the head saying 'I can't believe what this has turned out to be." Find out what clinical trial transparency is turning out to be for study sponsors – considerable work!

In this 90 minute audio conference, Patricia Teden, Principal of Teden Consulting LLC, will provide an update on recent ClinicalTrials.gov experiences, regulatory trends concerning clinical trial transparency and challenges for being compliant.

Click here for more information on the audio conference; or click here to order online or call 1-800-688-2421 (1-404-262-5474) to order the CD recording (MP3 format). Please mention priority code 19T10619-11793.

Maintaining Transparency between Physicians, Pharmaceutical and Medical Device Companies

Virtually all physicians, 94 percent, have some type of relationship with the pharmaceutical and medical device industries. Senators Charles Grassley and Herb Kohl introduced the Physician Payments Sunshine Act of 2009 that addresses potential conflict of interests between physicians and prescription product companies. The legislation, passed as a part of the Patient Protection Affordable Care Act and a Reconciliation package, now requires yearly reporting of all physician payments over a cumulative value of $100 dollars. The bill summarizes its disclosure obligations: "[The Act] Requires any manufacturer of a covered drug, device, biological, or medical supply that makes a payment or another transfer of value to a physician, a physician medical practice, or a physician group practice to report annually, in electronic form, specified information on such transactions to the Secretary of Health and Human Services." Criminal and civil penalties can be imposed for violations of the Act. Earlier, the Medicare Payment Advisory Commission (MedPAC) recommended in its March 2009 report that Congress should require all manufacturers and distributors of drugs, biological, medical devices and medical supplies to report their financial relationships.

What remains to be seen is how this law impacts the professional relationship between health care providers and the prescription product industry. In this 90 minute audio conference, Reed Smith's James Wood will provide insights on these measures and how they might transform the relationship between the practice of medicine and the creation of prescription products.

Click here for more information on the audio conference; or click here to order online or call 1-800-688-2421 (1-404-262-5474) to order the CD recording (MP3 format). Please mention priority code 19T10620-11817.

Walking the Off-Label Promotion Tightrope without a Net: Lessons Learned from Billion Dollar Fines and Consent Decrees

Prescription product companies find themselves in a quandary: FDA has recognized that discussion of unapproved uses of a product may be permissible while the Department of Justice watches for those who cross the line. Off-label promotion of FDA-approved products is a delicate tightrope act – precisely what prescription product manufacturers can and cannot say regarding off-label uses for their products remains unclear despite guidance from the FDA. Discussing off-label uses with physicians can quickly put you in legal hot water, which includes the threat of False Claim Act (FCA) suits, criminal indictments and civil litigation.

In addition to two billion dollar settlements, the new healthcare law provides new protections to whistle blowers. Now is the time to ensure you have a clear understanding of what can and what cannot be said about your company's products.

Be prepared! Register now for this 90-minute interactive audio conference and hear from attorney James Wood of Reed Smith to learn more about trends in recent False Claims Act suits and what the emerging best practices are in discussing uses of approved therapies for unapproved indications.

Click here for more information on the audio conference; or click here to order online or call 1-800-688-2421 (1-404-262-5474) to order the CD recording (MP3 format). Please mention priority code 19T10621-11823.

GMP Training Documentation: Steps to Prove Compliance

The FDA has made it clear that, for drugs and devices, GMP training must be documented: "Each manufacturer shall establish procedures for identifying training needs ... Training shall be documented."(from 21 CFR 820.25).

"Managers are expected to establish training programs that include... documentation of training and/or re-training"
Guidance for Industry Quality Systems Approach to Pharmaceutical CGMP Regulations

Sounds simple enough. And yet, warning letters continue to cite GMP training documentation violations, such as this letter from December 2009:

"Training records do not document training on [the] procedure The employee's training records do not document training on how to review quality control and quality assurance issues."

And this from January 2010:

"Your firm failed to provide documentation establishing that your lab analyst, who performs QC laboratory analyses, including microbial tests, was trained and qualified to perform laboratory tests."

Click here for more information on the audio conference; or click here to order online or call 1-800-688-2421 (1-404-262-5474) to order the CD recording (MP3 format). Please mention priority code 19T10622-11845.

The Park Doctrine: Protect Yourself from Personal Criminal Charges Stemming From Your Company's Misconduct

Imprisonment. Criminal fines. Debarment. These are just a few of the consequences that individual corporate officers in FDA-regulated companies can face if their company engages in misconduct. These penalties can be imposed even when the corporate officers were uninvolved in, and/or unaware of, the misconduct.

The FDA is increasingly targeting individual corporate officers. According to a recent letter written by Commissioner Hamburg, the FDA will "increase the appropriate use of misdemeanor prosecutions...to hold responsible corporate officials accountable."

How can you protect yourself from facing criminal penalties as a result of your company's activities? In this 90-minute audio conference, former FDA Chief Counsel Sheldon Bradshaw will discuss what you must do to avoid personal criminal prosecutions.

Click here for more information on the audio conference; or click here to order online or call 1-800-688-2421 (1-404-262-5474) to order the CD recording (MP3 format). Please mention priority code 19T10625-11904.

Data Monitoring Committees: Ensure Safety and Efficiency in Your Clinical Trial

Clinical trials, in particular large trials of long duration, are very expensive, highly complex, and of increasing importance to the development and registration of new drugs. They have come to require independent monitoring in order to assure that the trial is conducted in a manner that is ethical and sufficient to protect patients and to maintain the scientific validity of the data. Data Monitoring Committees have evolved over the last four to five decades to meet the needs and challenges of stakeholders.

Click here for more information on the audio conference; or click here to order online or call 1-800-688-2421 (1-404-262-5474) to order the CD recording (MP3 format). Please mention priority code 19T10623-11868.

Responding to 483s in a New Era of FDA Enforcement

Your company has just been issued a 483. When you respond, and what you say in your response, can reduce the risk of receiving a Warning Letter or other enforcement action.

In the past, it may have been months or years before the FDA took enforcement action.

Not anymore. In this era of increased FDA enforcement, companies that receive a 483 may have only 15 days to respond and correct issues before a Warning Letter is issued and/or other enforcement actions are taken. A timely and effective 483 response is increasingly important to avoid these negative ramifications.

How can you ensure that you are responding to 483s quickly and correctly? In this 90-minute audio conference, former FDA Deputy Associate Commissioner for Regulatory Affairs Steve Niedelman will discuss what you must do, from the time the investigator signs his/her name until the FDA indicates "no further action is necessary."

Click here for more information on the audio conference; or click here to order online or call 1-800-688-2421 (1-404-262-5474) to order the CD recording (MP3 format). Please mention priority code 19T10624-11887.

Clinical Trials in the Developing World: Planning, Conducting, Monitoring, Defending

With every month, a larger number of industry, academic and government-funded clinical trials are initiated outside the U.S., often in developing economies of South America, Southeast Asia, India, Africa or the states of the former Soviet Union.

While expanding clinical trials to developing countries can help companies to open new markets and expand research, it can also pose problems for those companies without sufficient knowledge of the strategies needed to plan and sustain these studies.

In this 90-minute audio conference, Mark Barnes will address the common issues and risks that arise in clinical trials in the developing world, and most importantly, how to plan, manage and monitor for risks of all types.

Click here for more information on the audio conference; or click here to order online or call 1-800-688-2421 (1-404-262-5474) to order the CD recording (MP3 format). Please mention priority code 19T10626-11920.

Social Media and Online Marketing in FDA-Regulated Companies: What You Need to Know to Prepare for Upcoming FDA Guidelines

Webpages and social networking sites are changing the way Americans obtain information on medical products. While marketing in these formats can garner positive attention for pharmaceutical and medical device companies, it can also pose serious risks.

The emergence and growth of the online realm has raised a host of new issues for marketers, such as who is responsible for product-related messaging and how reporting and regulatory obligations are defined.

Industry's efforts to leverage online promotions and the FDA's efforts to regulate them present a new set of legal and regulatory challenges for medical marketers and the lawyers and regulatory professionals who advise them.

With the FDA expected to release new guidelines pertaining to online marketing and social media this year, it is essential to begin preparing now. In this 90-minute audio conference, industry attorney Vernessa Pollard will explain how to effectively incorporate online marketing into your product marketing strategies while maintaining regulatory compliance.

Click here for more information on the audio conference; or click here to order online or call 1-800-688-2421 (1-404-262-5474) to order the CD recording (MP3 format). Please mention priority code 19T10627-11950.

The FDA's New "Bad Ad Program": Be Ready for Enforcement

The FDA recently unveiled an outreach program to educate healthcare professionals about the role they can play in guarding against violative or misleading prescription drug promotions. This effort, dubbed the "Bad Ad Program," encourages physicians to report questionable promotions, a move that effectively deputizes doctors as FDA investigators.

In this 90-minute audio conference, industry advertising and promotion expert Arnold Friede will examine the "Bad Ad Program" in detail. He will discuss the compliance and enforcement implications of the program, as well as its practical effect on the relationship between detailer and doctor. The audio conference will also examine approaches that companies might employ to minimize this new risk and how to build on existing compliance programs to address it.

Click here for more information on the audio conference; or click here to order online or call 1-800-688-2421 (1-404-262-5474) to order the CD recording (MP3 format). Please mention priority code 19T10628-11991.

The FDA's New Adverse Reaction Early Warning System: How Will It Impact Your Approved Drugs and Biologics?

The FDA's latest initiative will bring information about drug and biologic adverse events directly to patients and their health care providers. This program, a requirement of FDAAA (Section 915), will publish post-approval safety data on the FDA's website. It is intended to act as an early risk notification mechanism.

This new initiative raises many questions for those in the drug and vaccine industries, such as:

• What information will be posted?
• What information will be excluded?
• How will this affect approved drugs and biologics?

Click here for more information on the audio conference; or click here to order online or call 1-800-688-2421 (1-404-262-5474) to order the CD recording (MP3 format). Please mention priority code 19T10630-12071.

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