I'm looking forward to this course. RAPS has a lot of good general topic courses, but I miss more detailed issues specific courses, as a resource for RA professionals in smaller biotech who wear many hats and are who are constantly doing something for the first time as their company advances or gets hit by a specific challenge. Some bigger topics could be practical guidance on how to prep, execute, follow through for an IND, an NDA/BLA, an FDA meeting, for XYZ life cycle management activity. Or smaller tutorials on practical aspects of a maintenance activity (e.g., best practices for DSUR, module 1 preparation, iPSP, etc.). So, I'm curious to see how this course will look. Thank you!
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Anna Sedello, PhD, RAC-Drugs
Executive Director of Regulatory Affairs
Alpine Immune Sciences
Redwood City CA
United States
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Original Message:
Sent: 01-May-2024 11:27
From: Roya Zarrinnahad
Subject: Reviews and approvals
RAPS is developing a course on the regulatory review and approval process. The topics this course will cover include planning for reviews, managing reviews both internally and externally, and types of reviews.
We hope to incorporate authentic insights and lessons learned, so we would love to hear from you! Any story used in the course will be presented anonymously (unless otherwise requested).
If you have a few minutes, I'd appreciate any feedback you have here.
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Roya Zarrinnahad
Regulatory Affairs Professionals Society
Rockville MD
United States
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