Regulatory Readiness for the Analytical Development of CRISPR-Edited Products
Time: 10:00 am
day: Pre-Conference Day
Details:
This workshop will delve into the regulatory landscape for CRISPR-based therapies, highlighting new trials, case studies, and lessons from IND submissions. Participants will gain valuable insights into FDA guidelines, quality assurance practices, and regulatory requirements for both in vivo and in vitro CRISPR-based therapeutics.
Discussions will focus on maintaining regulatory consistency, anticipating changes, and ensuring data packages meet regulatory standards. At the end of the workshop, attendees will understand the strategies needed to advance CRISPR-based therapies from development to commercial approval, ensuring compliance and accelerating market entry
