About Event

The Ultimate Chance to Tackle Regulatory Challenges in the Cell & Gene Therapy Space

This summit is a premier gathering of cell and gene therapy regulatory experts, serving as a pivotal hub for C-Level Executives, Vice Presidents, and Directors of regulatory affairs and CMC. This October, prepare to delve into all aspects of cell and gene therapy regulation, from pre-IND to post-BLA, to benchmark best practices and prepare for all significant regulatory milestones.

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Cell & Gene Therapy Regulatory Affairs Summit - Branding  

Uncover the challenges in finding a regulatory pathway for in vivo gene editing and consider what first-in-human data packages and clinical follow-up plans should look like with Verve Therapeutics
Cell & Gene Therapy Regulatory Affairs Summit - Branding  

Discuss comparability protocols to understand the expectations of regulatory bodies and hear experiences from Bristol Myers Squibb and Vivet Therapeutics
Cell & Gene Therapy Regulatory Affairs Summit - Branding  

Benchmark best practices for handling batch failures from a global perspective with the National Health Institute
Cell & Gene Therapy Regulatory Affairs Summit - Branding  

Compare regulatory hurdles in the USA and Europe to plan for worldwide expansions with Quell Therapeutics and Orchard Therapeutics
Cell & Gene Therapy Regulatory Affairs Summit - Branding  

Break down Project Optimus to gain insights on translating pre-clinical dosing to efficacious doses in humans with Voyager Therapeutics
Cell & Gene Therapy Regulatory Affairs Summit - Branding  

Navigate designation assignments to understand the criteria for each designation and illuminate the advantages and differences between them with Prime Medicine

"This summit represents a pivotal opportunity to share insights, learn from industry leaders, and continue advancing the regulatory landscape to ensure the highest standards of safety and efficacy for these transformative treatments"
2024 Speaker, Global Senior Director, Analytical Sciences CMC, Cell & Gene Therapy, Orgenesis

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                • 8+ Hours of Industry Networking
                • 20+ Regulatory Expert Speakers
                • 2 Interactive Deep-Dive Workshops
                • & Much More!

               

               

           

           

       

       

 

 

           

           

       

       

 

 

           

           

           

       

       

 

 

 

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Cell & Gene Therapy Regulatory Affairs Summit - Full Agenda
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