Expedited Approval Pathways in the US: Best Ways to Get the Most Incentives
Date: April 14, 2025
Duration: 60 Minutes
Time: 12 PM EST
- Assessing the eligibility of a product for an expedited approval pathway: drugs, biologics and medical devices
- Best practices for format, style, and organization of each type of expedited approval pathway
- Best time in the development timeline to apply for each designation
- Pros and cons of applying for each designation
- What to do when a given designation is rejected: general processes to re-apply and appeal
- Managing public information related to each expedited approval pathway
- Common errors and potential solutions
This webinar, presented by a leading regulatory affairs expert in expedited approval pathways, discusses all the expedited approval pathways available for FDA regulated products. Scope, process to obtain, and key strategies to maximize benefit will be discussed with case studies and examples from the experts extensive experience. The seminar will highlight best practices for using each expedited approval pathway, dos and don’ts, common issues, and potential solutions. Successfully tested strategies for format, tone, organization, and presentation of each expedited approval pathway will be discussed. The training is designed to provide a well-rounded training to all stakeholders in expedited approval pathways for FDA regulated industry.
This webinar will provide valuable assistance to all personnel in:
- Regulatory affairs professionals
- Senior management executives (CEO, COO, CFO, etc)
- Project Managers
- Clinical trial specialists
- Regulatory Compliance Associates and Managers
- People investing in drug and biologics products
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
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.
