Pathways to Pre-Clinical Development Success - Focus on ATMPs

he sessions are designed to provide attendees with a regulatory scientific approach for successful translation of ATMPs into the clinic. We will aim to provide an understanding of pre-clinical development pathways and requirements for ATMPs leading to the most expedited regulatory strategy in Europe, the US and beyond. Potential challenges in the development and registration of these products will also be discussed, to provide practical advice as well as highlight key aspects determining successful regulatory submissions.

Topics: 
• The value of regulatory strategies in the early development of ATMPs 
• CMC issues that impact the development of gene and cell therapy programs
• Challenges in pre-clinical development of ATMPs
• Assay development
• Toxicology studies and their design

For more information please sign up to the registration page.