Introduction to the FDA and Your First FDA Meeting

Why Should You Attend:

This webinar will delve into how the FDA is organized and how it operates. It will review the drug development process and key regulatory submissions and help participants understand why they should always take advantage of your opportunities to meet with FDA.

Participants will also learn how to prepare the necessary documentation and their team for FDA’s visit. From learning how to request an FDA meeting to understanding how FDA prepares for the meeting with you, this course will cover all the bases.

Learning Objectives:

• Learn how the FDA is organized and how it operates
• Review and overview of the drug development process and key regulatory submissions
• Learn why you should always take advantage of your opportunities to meet with FDA
• Learn the different types of FDA meetings
• Learn how to prepare your documentation and your team for the FDA
• Learn how to request a FDA meeting
• Learn what goes into an organized briefing book
• Learn how FDA prepares for the meeting with you
• Learn how to conduct the meeting and how to appropriately debrief

Areas Covered in the Webinar:

• FDA mandate and structure
• Deciding if you are ready to meet with FDA and when
• Correct way and time to request a meeting and what FDA will need to give you the best feedback
• How to behave and respond during the meeting
• Dos and Donts for your FDA interactions (avoid the pitfalls)
• What to do after the meeting

Who Will Benefit:

• Professionals who are just beginning their regulatory career
• Experienced staff that haven’t led a FDA meeting before or who would like a refresher
• Members of clinical development teams who have never prepared for a FDA meeting previously
• International (ex-US) development team members that have been to health authority meetings outside the US, but who lack FDA specific knowledge
• Startup and small biotech company employees getting ready to take their first development compound into the clinic

Instructor Profile:

Andrew S. Verderame, MBA, RAC leads the expert staff at PharmaLex US, providing FDA-specific guidance and regulatory consulting services. Their clients benefit from his wealth of experience, including leading over one hundred meetings with FDA, managing multi-site regulatory teams for both large and small pharmaceutical companies, and presenting to FDA advisory committees with successful outcomes. He has led several successful NDA and major efficacy supplement submission and approval processes, and has previously held senior regulatory affairs positions at EMD Serono, Replidyne and Bayer HealthCare.

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