How to "Win" FDA's Support for Your Clinical Development Program

How to “Win” FDA’s Support for Your Clinical Development Program

Date: January 29, 2025
Duration: 60 Minutes
Time: 12 PM EST

All development programs are not alike. What differentiates a smart development program from others is that such programs not only are built on a deep understanding of the applicable regulations and guidance documents but also a thorough awareness of the changing circumstances and expectations. Meetings with FDA to discuss the development program is just one piece of this effort to build a rapport with the regulators. Carefully crafted experiments involving dedicated subject matter experts, clinical trial programs attuned with the patient perspectives, timely pursuit of regulatory designations, adequate resource allocation to reduce risks, and constant involvement of FDA in the sponsor decision process can contribute to creating an environment for strong FDA support for a given program. FDA must consider not just the technical aspects of given development plan but also public health needs, patient opinions, policy, and scientific merits to lend its support. The regulatory strategy should be integral and dynamic.

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.

Areas Covered in the Session:

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

Who will benefit:

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

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

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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.

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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.