Short Course: Regulatory Pathways for the Translation EV Therapeutics from Pre-Clinical Research to the Clinic
Wed Oct 23, 2024 4:45 PM - 6:15 PM
Cripps Court Magdalene College Cambridge, CB3 0AG
Description
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
Location
Cripps Court Magdalene College Cambridge, CB3 0AG