How to Ace an FDA Meeting
Date: May 20, 2025
Duration: 60 Minutes
Time: 12 PM EST
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.
- 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
- Regulatory affairs personnel
- Regulatory intelligence personnel
- Senior management executives (CEO, COO, CFO, etc)
- Project Managers
- People interested in investing in the FDA-regulated industry
Speaker: Mukesh Kumar
PhD, RAC | CEO, FDAMap
For more info, fill the box below. We will contact you within 24 hrs.
Webinar Fee
Prices are in US Dollars.
The registration fee includes: The live webinar & all related course materials.
Terms & Conditions to register for the Webinar
Your Registration for the workshop is subject to following terms and conditions. If you need any clarification before registering for this webinar please email us at info@fdamap.com
Payment
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Cancellations & Substitutions:
Written cancellations through fax or email (from the person who has registered for this conference) received at least 5 business days prior to the start date of the event will receive a refund — less a $30 administration fee. No cancellations will be accepted — nor refunds issued — within 5 business days before the start date of the event. You may however, choose to substitute the webinar for which you are registered with some other webinar in the future.
On request by email or fax (before the seminar) a credit for the amount paid minus administration fees ($30) will be transferred to any future FDA Map event and a credit note will be issued. No-shows will be charged the full amount.
Webinar material will be uploaded on the website 24 hours before the scheduled date of the webinar. In case it is not available on the website due to some technical issues, we will email the material a few hours before the start of the webinar.
In the event FDA Map cancels the webinar, FDA Map will issue a full refund to all the registrants for that webinar. Some topics and speakers may be subject to change without notice.
