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Successful FDA Meeting Preparation and Conduct

4578
Duration : 90 Minutes
Peggy J Berry,

Peggy J. Berry, MBA, RAC, is the President & CEO at Synergy Consulting where she provides consulting services to companies in all aspects of drug development. She also provides group and one-on-one training in drug development, regulatory affairs and project management topics. Prior to founding Synergy Consulting in 2015, Read more

The FDA has published guidance regarding the types of meetings that will generally be granted and the information needed to conduct the meeting. However, the guidance tend to be general and interpreted in multiple ways. This topic will provide practical examples and suggestions for standard meetings as well as requesting and conducting non-typical meetings (such as during fast track, clinical hold, or for breakthrough therapy topics).

Rehearsal, post-meeting follow-up, and documenting nonformal FDA interactions will also be discussed in detail.

Course Objectives:

Obtaining feedback from the FDA at various times during the development process is crucial to the company to ensure that resources are not wasted and alignment is achieved. This session will provide you with the information you need to request, prepare for and conduct meetings with the FDA to maximize successful outcomes and receive actionable direction and information.

Course Outline:

• Standard FDA meeting types and timing
• General qualifying requirements
• Preparing the meeting request
• Preparing the briefing document
• Rehearsing for the meeting
• Conduct of the meeting
• Post-meeting follow up
• Non-typical FDA meetings
• Preparation for non-typical meetings
• Documenting informal meetings and correspondence
• Reference to meetings during future submissions

What You Get:

• Training Materials
• Live Q&A Session with our Expert
• Participation Certificate
• Access to Signup Community (Optional)
• Reward Points

Who Will Benefit:

Senior Managers and those who have responsibility for developing new products and gaining FDA approval, as well as those that have key collateral roles in reviewing and/or preparing FDA submission documentation for drug and device firms, including officials from these areas within regulated companies:

• Regulatory Affairs
• Marketing
• Medical Affairs
• Legal
• Regulatory Compliance

Please reach us at 1-888-844-8963 for any further assistance or if you wish to register

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