FDA-mandated postmarket studies are coming. They are likely to be complex in design and large in scale, with exacting endpoints.
You can’t escape them … and, if you fail to comply, you could be liable for fines of up to $1,000,000.
What should you do? Where do you begin to learn the details? Attend this invaluable webinar lead by two experts with 40-plus years of combined experience with postapproval studies …
With its newly held authority to demand postmarket studies, the FDA is abandoning a long-standing policy of negotiating postmarket commitments with sponsors — and will now set mandatory objectives and timelines.
According to the Office of New Drugs Director John Jenkins, the agency will soon authorize post approval studies that are complex, large in scale (possibly 500,000 patients per arm) and with exacting endpoints.
What does this mean for your company?
First, complying with these new requirements will not be easy — because there is no one-size-fits-all guidance to help a particular drug or drug class prepare for the studies. Even the FDA admits it lacks the expertise to design the studies … so it will turn to its advisory committees to address the particulars of each product and make specific recommendations.
It’s logical that companies like yours must get ready now to have the proper expertise in place to manage FDA-compliant studies, create on-the-ground strategies for meeting the FDA’s requirements and develop a clear understanding of the steps to take whenever the FDA guidance is unclear.
But there’s so much more to learn …
And unfortunately, if you fail to deliver the mandated studies on time or within protocol, you could be fined. Civil penalties go up to $250,000 per violation — and even higher to a maximum of $1,000,000 for all violations in a single proceeding.
To get a handle on this complex issue, you need reliable answers to your hardest questions — from a source you can trust.
That source was the FDAnews webinar Phase IV Trials Mandated by FDAAA, held March 4, 2010, and featuring experts Dr. Kelly Davis and Peggy Schrammel of United BioSource Corporation.
With more than 40 years of combined experience, they will bring you up to speed on the agency’s thinking into which studies will be mandated ... how advisory committees will review the proposals ... and what sponsors might expect the FDA will require of them … and much more.
Dr. Davis is a 25-year veteran of the pharmaceutical industry with extensive experience in clinical trials. Ms. Schrammel has more than 16 years of experience designing and executing postapproval studies and patient registries across multiple therapeutic areas.
You won’t want to miss out on these critical presentations. In just 90 minutes, without leaving your office, you’ll receieve must-have specifics like:
Dr. Davis and Ms. Schrammel have the answers you need. Everyone in your organization with a role in Phase IV trials deserves to hear this event — and they can do so, at a cost that won’t break the budget.
One day the FDA will likely tap you for a post-approval study: Phase IV trials already account for nearly 30 percent of all studies and the number is growing. Prepare now; make plans to order the audio CD/Transcript for Phase IV trials.
Kelly Davis, M.D. is currently vice president, Safety, Epidemiology & Risk Management at United BioSource Corporation (UBC). Dr. Davis is an endocrinologist with more than 25 years of experience in medicine as a physician, clinical researcher and pharmaceutical executive. She provides consulting services to clients in risk management, product safety and late-stage development of drugs and biologics. She has extensive experience in clinical trial and observational study design, development strategy in many disease areas and design and implementation of Risk Evaluation and Mitigation Strategies (REMS). She is a frequent advisor to companies planning their postapproval safety/risk assessment studies. Before joining UBC, Dr. Davis was vice president and therapeutic area head for Inflammation, Metabolism and Gastroenterology in Clinical Research and Development at Wyeth Pharmaceuticals.
Peggy Schrammel is vice president, Registries and Post Approval Development for UBC. She brings more than 16 years of experience designing and executing post-approval studies and patient registries across multiple therapeutic areas, with foundations in pharmacoeconomics and outcomes research. Having held various senior-level positions within the CRO industry, Ms. Schrammel has headed up global operational divisions, launched various corporate initiatives in the medical device and endpoint adjudication areas and been responsible for strategic marketing and business development in the postapproval arena. She is a frequent speaker at well-known conferences on subjects pertinent to postapproval research.