How to “Win” FDA’s Support for Your Clinical Development Program
Date: January 29, 2025
Duration: 60 Minutes
Time: 12 PM EST
This seminar will discuss ways developers can take a wholistic approaches to create a program that can win FDA’s support. The speaker will discuss how companies can develop competitive regulatory programs. The seminar will highlight key strategies to maintain high quality proactive regulatory intelligence, dos and don’ts, common areas of concern, and trouble-shooting practices. The pros and cons of the “follow-the-leader” approach, and investing in new ways of working will be discussed. These innovative business approaches are also useful for established organizations to create lean, adaptive regulatory affairs teams.
- Basic elements of regulatory intelligence
- How to select the appropriate subject matter expert(s)
- Patient Focused Drug Development (PFDD) in early stages
- Strategies for using social tools to create awareness of your product
- Criteria for using regulatory incentives diligently
- Ways to interact with FDA: beyond FDA meetings
- Regulatory gap analysis and strategic plans
- Regulatory Affairs Personnel
- Clinical Trial Professionals
- Clinical Research Professionals
- Quality Assurance Personnel
- Vice presidents, Directors and 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.
