ComplianceOnline

Planning for a Successful Pre-IDE Meeting with FDA

Instructor: Stuart Portnoy
Product ID: 701603
  • Duration: 60 Min

recorded version

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Training CD

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This Webinar presents a best practices approach to planning and executing a successful Pre-IDE Meeting with FDA. The speaker is a former CDRH Division of Cardiovascular Devices (DCD) Acting Deputy Director and Branch Chief who has significant insights into the critical factors which lead to a successful Pre-IDE interaction with FDA. The session will discuss and provide specific recommendations on how to prepare a high quality and focused Pre-IDE Submission followed by planning for a successful and interactive Pre-IDE Meeting with the FDA review team.

Why Should You Attend :
There is no substitute for a face-to-face meeting with FDA. Properly planning and executing this critical early interaction with FDA is one of the most important determinants in successfully establishing a productive and trusting relationship between the FDA and your product development team and senior management.

In this webinar, some important Pre-IDE planning considerations to be discussed include the following:

  • How to get the most out of your FDA meeting (which may last only an hour).
  • The do's and don’ts for your PowerPoint Presentation.
  • Specific considerations for how to start off your relationship with FDA on the right foot.
  • Managing a bad situation -- i.e., an adversarial FDA reviewer or manager.
  • Negotiating tactics and understanding how to choose your battles carefully.

Areas Covered in the Seminar:

  • Why a Face to Face Meeting?
  • When to Meet with FDA?
  • Pre-IDE Meeting -- Scheduling Timeframe.
  • The Pre-IDE Process -- What it is and what it’s not.
  • How to Prepare a High Quality Pre-IDE Submission.
    • Important Considerations for Content
    • Meeting Agenda and Attendees
    • "Questions to the FDA"
  • Pre-IDE Meeting Preparation.
    • PowerPoint Presentation.
    • Rehearsal Meeting
  • Pre-IDE Meeting.
    • Getting the Most out of Your Meeting
    • Negotiating Tactics
    • Meeting Closure, Minutes, & Follow-Up
  • It’s your meeting, so make sure that you get what need.

Several interactive Regulatory Riddles will be presented for clear understanding of different situations such as:

  • Animal Studies -- Is it necessary to have completed all animal studies before meeting with FDA?
  • PowerPoint Presentation -- How long, 15 minutes? Do you even need a PP presentation?
  • Physician Attendee -- Should you have a physician attend the meeting?
  • Dealing with some Bad Situations -- Adversarial FDA Reviewer or Manager, Meeting starts late or runs long, FDA doesn't have a qualified expert at the meeting, One of your own presenters is falling apart.

Who Will Benefit:
This webinar will provide valuable assistance to all medical device manufacturers.The employees who will benefit include:

  • Regulatory Affairs
  • Marketing Department
  • Compliance Specialists
  • Clinical Project Leaders

Instructor Profile:
Stuart Portnoy, MD is Senior Consultant, Medical Devices, Biologics Consulting Group, Inc., where he advises medical device manufacturers regarding regulatory strategy, clinical trial design issues, and technical considerations to gain FDA market-approval for their products. He previously worked as a consultant at PharmaNet for 5 years and before that, at FDA for 8 years including positions as Branch Chief of Interventional Cardiology Devices and Acting Deputy Director of the Division of Cardiovascular Devices in the Center for Devices and Radiological Health. While at FDA, Dr. Portnoy performed the clinical review of a wide range of cardiac devices and was an agency leader in developing the now well-established multicenter review practices for evaluating drug-eluting stents and other combination products. Dr. Portnoy is a graduate of George Washington University School of Medicine and also has an MS in Bioengineering from the University of Pennsylvania.

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