If you are developing products for serious and life-threatening illnesses with unmet medical needs, there are several mechanisms offered by FDA that can accelerate your product development and the review of your BLA/NDA.
This webinar will provide you some background on each of the tools and how you can leverage them to your advantage. The tools include – Fast Track (FTD), Breakthrough Therapy Designation (BTD), Regenerative Medicine and Advanced Therapies (RMAT), accelerated approval and priority review.
Some key learning points:
- Understand various mechanisms created by FDA to speed the product development and the BLA/NDA review
- Comprehend the types of situation to which these tools are applicable
- Familiar with the differences in the requirements to obtain each tool
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Sample of the webinar
Featured Speakers
Charlene Revel, PharmD, MSc.
Senior Regulatory Scientist, Drugs and Biologics
Charlene has great experience in the implementation of global regulatory and scientific strategies as well as submissions for the development and marketing of biologics products, drugs and medical devices.
Michael Day, PhD
Senior Director, Regulatory Science
As Senior Director Regulatory Science at VCLS, Michael (Mike) is responsible for providing both regulatory strategy and CMC consulting services…
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Mark Gauthier
Senior Director, Regulatory Science, Drugs & Biologics
As Senior Director, Regulatory Science, Mark is responsible for assisting clients to define the regulatory strategies for the global development and…
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