Dispute Resolutions with FDA: Clinical, GMP, and Application Reviews
Date: May 16, 2025
Duration: 60 Minutes
Time: 12 PM EST
Why should I attend:
1. Invaluable Guidance from Industry Expert: Our speaker, well-versed in FDA regulations and dispute resolution, will share his insights and expertise. You’ll receive expert guidance on understanding the FDA’s procedures and tips for navigating the dispute resolution process, whether formally through the centers or informally through the ombudsman’s office.
2. Strategic Preparation for Meetings: Preparation is key to a successful resolution. Learn how to prepare thoroughly for meetings with the FDA, ensuring you present a strong case backed by solid evidence. Our seminar will teach you how to compile a comprehensive list of critical questions and identify potential weaknesses in your responses, empowering you to address challenges confidently.
3. Harness the Power of External Reviewers: Gain a competitive edge by understanding how to include external “reviewers” to add an independent aspect to the evaluation. Discover how this approach can bolster your case and provide valuable perspectives that may have otherwise been overlooked.
4. Leverage Regulatory Considerations: Understanding how the FDA reviews data is essential to building a compelling case. Learn how regulatory history associated with your product is cumulative and holds significance during reviews. Discover why human experience data is crucial and how it can substantially impact the agency’s decision-making process.
5. Systematic and Amicable Conflict Resolution: Our seminar emphasizes the importance of pursuing resolution systematically and amicably. Our expert will guide you on how to present information that supports the approval of your product under review, increasing the likelihood of a positive outcome.
6. Weighing the Decision to Fight: Sometimes, picking a fight with the FDA may not be the most fruitful approach. Gain valuable insights into assessing the risks and potential outcomes before engaging in a dispute. Understanding the high likelihood of failure in some cases can save you time, effort, and resources.
Join us for this one-of-a-kind seminar and empower yourself with the tools and knowledge necessary to tackle FDA disputes with confidence. The benefits of mastering the art of dispute resolution will extend far beyond just the FDA; you’ll develop skills that will serve you well in various aspects of your professional life.
- Regulatory affairs professionals
- Clinical Research Professionals
- Principal Investigators
- Site Managers and Research Coordinators
- Contract Research Organizations (CROs) Staffs
- Institutional Review Board (IRB) Members
- Drug discovery and development professionals (R&D and CMC)
- Clinical trial managers
- Project Managers and Clinical trial specialists
- Pharmaceutical and Biotech Industry Professionals involved in clinical trial planning and execution.
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.
