Webinars >>FDA Meetings
All About FDA Meetings: Arrange, Prepare, Attend and Follow-Up

Formal meetings with the FDA are run like an efficient machine. The sponsor is given very specific time to discuss and usually only one meeting of a kind is available. FDA reserves the rights to deny meetings if it feels that the requester is ill-prepared; and companies frequently come back from a meeting with FDA not very pleased with the outcome. One needs to go well-prepared to these meetings with the FDA, and fully understand the rules of these meetings to make them work for you. This seminar will discuss strategies to make the most of a meeting with FDA.
Why should you attend:
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Getting direct feedback from FDA is essential for all manufacturers. But FDA is very selective about granting meetings. These meetings can be used to understand FDA’s concerns and get clarity on your plans to address the same. While there are quite a few guidance documents on FDA meetings, none explains the practical strategic aspects of these meetings that make them successful for the requester. This seminar is presented by one of the top regulatory experts with hundreds of FDA meetings spanning 2 decades, who will share traditional approaches, conventions wisdom, and tested strategies for getting the most out of an FDA meeting. The seminar will discuss the do’s and don’ts of FDA meetings describing common mistakes and possible solutions using real-life case studies. Techniques in preparing for FDA meetings using case studies and examples will be discussed. This is a must seminar for anyone planning to meet FDA in the near future.
Areas Covered in the Session:
  • Who can request a meeting and who can’t
  • What are various kinds of meetings with FDA
  • Best practices for mock meeting before the real deal
  • Logistics of FDA meetings
  • Do’s and don’ts of an FDA meeting
  • What works and what doesn’t when negotiating with FDA
Who will benefit:
  • Regulatory affairs personnel
  • Regulatory intelligence personnel
  • Senior management executives (CEO, COO, CFO, etc)
  • Project Managers
  • People interested in investing in the FDA-regulated industry
Date: November 7, 2018
​Duration: ​60 Minutes
​Time: 12PM EST

Speaker: Mukesh Kumar
​PhD, RAC | Brij Strategic Consultations,  USA
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    For more info, fill the box below. We will contact you within 24 hrs.
For additional information on the workshop agenda and logistics, please call 410-501-5777 or email: info@fdamap.com