How to Prepare for an FDA Panel Meeting

Why should I take this eConference?
You'll get a focused look at the FDA advisory committee and panel meeting process  and receive practical tips to prepare you and your company for a panel meeting.

 

Description:
FDA is facing many challenges in the review of a growing number of innovative technologies. They may seek input and advice from one of their 18 scientific advisory panels on any class of medical device. These panels are made up of independent experts, scientific and medical professionals. Of their seven functions, your most direct involvement may be when they provide comment on the adequacy of safety and effectiveness data you submit.

 

During a panel meeting, you--as the product sponsor--present an overview of your safety and efficacy evidence and respond to questions raised by the panel members. Panel meetings are held at various times during the year, are open to the public, and often garner considerable attention from the media.

In this eConference, Dr. Garvey will provide an overview of the FDA advisory panel process and points to consider in preparing for a panel meeting developed from FDA documents and panel transcripts, as well as personal communications with FDA staff and professionals who have helped companies prepare successfully for panel meetings.

You will learn:
• How FDA advisory committees and panel meetings came about, how are they constituted, and how they have been and are being used by FDA;
• When an FDA panel meeting is necessary;
• The mechanics of a panel meeting;
• A look at panel meeting transcripts;
• Points to consider in preparing for a panel meeting.

You will get:
• A PDF file of Dr. Garvey's slides
• Medical Devices Advisory Committee Charter
• Instructions on how to access panel meeting schedules
• Directions on when to download preparatory documents for panel meetings
• Directions on where to download panel meeting minutes
• 0.15 CEUs and Certificate of Attendance

Who should attend:
This eConference is designed for 1) regulatory and clinical professional who will prepare and/or present materials at a panel meeting, and 2) business leaders and others whose products are likely to be reviewed by an FDA panel.

Presenter:
Clinical Device Group is proud to present Dr. Patricia L. Garvey, an independent regulatory consultant specializing in medical devices. Dr. Garvey recently retired from Edwards Lifesciences LLC after an 11-year tenure where she held the position of Corporate Vice President, Regulatory, Quality and Clinical Affairs from 2002-2006. Edwards designs and manufactures medical devices to treat advanced cardiovascular disease, including bioprosthetic surgical and percutaneous heart valves, vascular surgical products, peripheral vascular stents, and hemodynamic monitoring catheters and monitors. Dr. Garvey began her career in the medical devices industry in 1986 and has held various regulatory and clinical research positions in ophthalmic device firms, including Pharmacia Ophthalmics and Allergan prior to joining Edwards in 1995. Dr. Garvey received a B.A. in psychology and Ph.D. in biopsychology from the University of California, Santa Barbara. She has served on the Global Harmonization Task Force (GHTF) Study Group 5 (Clinical Evidence), represented Edwards on the AdvaMed Technology and Regulation Board Committee and numerous working groups, and is an Advisory Board Member for the Master’s Program in Regulatory Science in the University of Southern California School of Pharmacy. Dr. Garvey has also served on the Centers for Medicare and Medicaid Services (CMS) Medicare Coverage Advisory Committee (MCAC) and was a member of the External Science Review Committee for FDA’s Center for Devices and Radiological Health (CDRH) in 2001. Dr. Garvey can be reached at pgarvey@cox.net.

The purchase is $401 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.