Navigating Regulatory Requirements for Gene Therapy Potency Assays
Time: 9:00 am
day: Conference Day 1
Details:
This session delves into the complexities of regulatory strategies for gene therapy potency assays, providing an in-depth exploration of both early and ongoing regulatory engagement. Participants will learn how to build effective relationships with regulatory bodies and prepare for regulatory meetings and submissions.
Designed to equip participants with the knowledge and skills to navigate the regulatory landscape effectively, this session offers insights and practical applications that extend beyond the main conference. With contributions from experts whose gene therapy products are at various stages of clinical development, attendees are guaranteed to gain valuable insights that can be applied to their current or upcoming regulatory applications and assay development strategies.
