How to Apply for a Breakthrough Therapy Designation and Win It
Date: March 25, 2025
Duration: 60 Minutes
Time: 12 PM EST
- Assessing the eligibility of a product for BTD
- Best practices for format, style, and organization of the BTD application
- Best time in the development timeline to apply for the BTD
- Pros and cons of applying for the BTD
- What to do when the BTD is rejected: process to re-apply and appeal
- Managing public information related to the BTD
- Common errors and potential solutions
This webinar, presented by a leading regulatory affairs expert with successful BTDs, discusses FDA expectations from BTD requests, the best practices to write a BTD request, and pros and cons of applying for a BTD. The session will highlight key regulatory requirements, dos and don’ts, common areas of concern, and trouble-shooting BTD requests using case studies and examples from the presenter’s vast experience helping companies big and small in successfully applying for a BTD. The format and rules governing BTD request will be discussed along with success and challenge factors. The training is designed to provide a well-rounded training to all stakeholders in all aspects of the BTD application process.
- Regulatory Affairs Personnel
- 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.
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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.
