Getting the Most Out of Your Regulatory Interactions Sharing Best Practice & Ideal Ways of Working
Time: 9:05 am
day: Pre-Conference Workshop Day
Details:
Join us for an interactive workshop where where leading regulatory experts come together to explore the art of optimizing regulatory interactions in the rapidly evolving field of gene therapy.
This session aims to provide attendees with valuable insights, best practices, and practical strategies to foster effective and successful interactions with regulatory agencies.
- Clarifying best practice for early interactions with regulatory bodies, exploring timelines
- Learn how to prepare effectively for various types of regulatory interactions, such as pre-IND meetings, end-of-Phase 2 meetings, and pre-BLA meetings
- Differentiating how type C and type D meetings can be used and the nature of topics that we should provide feedback on
- Navigating regulatory hurdles and gain insights into common regulatory hurdles faced by gene therapy developers and strategies to overcome them
- Discuss real-world case studies and share experiences of successfully addressing challenges during regulatory interactions
