Procedures for Handling Post-Approval Studies Imposed by PMA Order

Why should you take this eConference?
A post-approval study requirement could delay, or even jeopardize, your approval if you are not fully prepared. In this eConference you will learn what you need to keep the approval approach to post-approval study requirements. Even if you are experienced in the FDA regulation you are facing new procedures and requirements.

You will learn:
- Tools and understanding you need to develop a complete strategy regarding post-approval studies.
- Should you offer to do a study?
- Will reaching agreement with FDA on the protocol delay your approval for another six month review cycle? How can a delay be avoided?
- How does FDA organizationally handle post-approval studies? Who are the key officials? Who can help if problems arise?
- What information will be made public?
- May FDA withdraw an approval based upon the results of a post-approval study?

Who should attend:
- Device Manufacturers
- Sponsors
- Regulators

You will receive:
- Slides
- Handouts
- An expert speaker
- A chance to listen to other's QnA
- CEUs & Certificate

Presenter:
Clinical Device Group is proud to present Mr. Jeffrey Shapiro. Mr. Shapiro is one of the directors at Hyman, Phelps & McNamara Law firm in Washington, D.C. Mr. Shapiro has represented health care companies on FDA-related matters since 1994. He advises companies on a wide variety of issues in the areas of medical devices, combination products, and human tissue products, including product approvals, marketing, clinical studies, jurisdictional issues, and enforcement. Mr. Shapiro can be reached at JShapiro@hpm.com.

The purchase is $402 for the CD. Event materials are available on the CD itself. Each attendee is eligible for 0.15 CEUs upon completing the course feedback via the link provided with the event materials. Click here to purchase.