Event Details
2nd Cell and Gene Therapy Regulatory Affairs Summit
With major FDA changes already reshaping the regulatory landscape - and global agencies ramping up scrutiny - 2025 is a pivotal year for cell and gene therapy regulatory professionals. With CBER leadership changes, new FDA draft guidance on post-approval CMC, and potency assays facing heightened scrutiny, the environment is rapidly evolving. Global efforts to align expectations are also gaining momentum, with ANVISA and Health Canada joining harmonization initiatives, and ICH Q12 implementation for CGTs underway.
The 2nd Cell and Gene Therapy Regulatory Affairs Summit is the only industry-led event focused exclusively on CGT regulatory strategy. Join 80+ experts this December in Washington, D.C. for real-world case studies, insights from regulators, and deep dives into IND-to-BLA planning, global alignment, and emerging modalities.
If you're navigating nonclinical, clinical, or CMC submissions, this is your essential forum to stay ahead of shifting expectations and accelerate CGT approvals in 2025 and beyond.
The 2nd Cell and Gene Therapy Regulatory Affairs Summit is the only industry-led event focused exclusively on CGT regulatory strategy. Join 80+ experts this December in Washington, D.C. for real-world case studies, insights from regulators, and deep dives into IND-to-BLA planning, global alignment, and emerging modalities.
If you're navigating nonclinical, clinical, or CMC submissions, this is your essential forum to stay ahead of shifting expectations and accelerate CGT approvals in 2025 and beyond.
Entry Fees
Free Registration
Categories
Event Frequency
One Time
Event Timings
(GMT-5:00) Central Time (US and Canada)
09:00 AM - 05:00 PM (Dec 02, Dec 03, Dec 04) (Public)
Speakers
Allen Callaway
Distinguished Scientist, CMC Regulatory Affairs Johnson and Johnson
Brett Howard
Senior Director, Regulatory Policy U.S. Pharmacopeia
Brian Furmanski
Chief Regulatory Officer and Head of Global Regulatory Affairs Kriya Therapeutics
Carl Denny
Senior Vice President and Head of Regulatory Affairs Abeona Therapeutics
Organizer
Hanson Wade
4 Followers
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Hanson Wade specialises in bringing people together through outstanding business conferences and year round community contact.
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Event Location
Hilton Washington DC Capitol Hill
525 New Jersey Avenue Northwest ,
Washington 20001, District of Columbia, United States
Washington 20001, District of Columbia, United States
Official Link :
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