How to Ace an FDA Meeting

Date: May 20, 2025
Duration: 60 Minutes
Time: 12 PM EST

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:
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

Speaker: Mukesh Kumar

PhD, RAC | CEO, FDAMap

For more info, fill the box below. We will contact you within 24 hrs.

Webinar Fee

Single Registration

$199

Group Registration (5 Persons)

$699

Group Registration (10 Persons)

$1199

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

We accept credit card, debit card, and PayPal.

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.