Short Course: Regulatory Pathways for the Translation EV Therapeutics from Pre-Clinical Research to the Clinic

To register for the Regulatory Pathways Short Course, you must first register for the Precision EV Forum 2024

Short Course: Regulatory Pathways for the Translation EV Therapeutics from Pre-Clinical Research to the Clinic

16:45 Introduction to the short course and overview of learnings
• Finding clarity on which guidance to follow, what is a Regulatory Binder, and how should they be implemented?
• Cell Lines, GMP and CMC
• Pre-Clinical Efficacy, Safety and Toxicity, Pharmacokinetics and dynamics studies for IND application
• Getting to the clinic…so what’s next, Phase I, II and III, BLA and Approval?
• Regulatory pitfalls to avoid for EV therapeutics

16:55 Introduction of attendees, so each person can say who they are and why they are here?

17:00 Regulatory Binder Presentation, Handout and Q&A

17:15 Cell Lines, CMC and GMP – Presentation and Discussion

17:30 Pre-Clinical studies for IND application – Presentation and Discussion

17:45 In the clinic, Phase I, II and III, NDA and Approval – Presentation and Discussion

18:00 Short course summary and takeaways, final Q&A

Short Course Leader: Maureen Merrifield, Chief Regulatory Officer, Rion