ComplianceOnline

Introduction to the FDA and Your First FDA Meeting

Instructor: Andrew S Verderame
Product ID: 704338
  • Duration: 60 Min

recorded version

$229.00
1x Person - Unlimited viewing for 6 Months
(For multiple locations contact Customer Care)
Recorded Link and Ref. material will be available in My CO Section

Training CD

$399.00
One CD is for usage in one location only.
(For multiple locations contact Customer Care)
CD and Ref. material will be shipped within 15 business days

Customer Care

Fax: +1-650-565-8542

Email: customercare@complianceonline.com

Read Frequently Asked Questions

This FDA training program will guide attendees on how to get the best advice from FDA with the proper actions before, during and after your 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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Refund Policy

Registrants may cancel up to two working days prior to the course start date and will receive a letter of credit to be used towards a future course up to one year from date of issuance. ComplianceOnline would process/provide refund if the Live Webinar has been cancelled. The attendee could choose between the recorded version of the webinar or refund for any cancelled webinar. Refunds will not be given to participants who do not show up for the webinar. On-Demand Recordings can be requested in exchange.

Webinar may be cancelled due to lack of enrolment or unavoidable factors. Registrants will be notified 24hours in advance if a cancellation occurs. Substitutions can happen any time.

If you have any concern about the content of the webinar and not satisfied please contact us at below email or by call mentioning your feedback for resolution of the matter.

We respect feedback/opinions of our customers which enables us to improve our products and services. To contact us please email customercare@complianceonline.com call +1-888-717-2436 (Toll Free).

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