BIH Workshop (in English) – How to Translate ATMPs into the Clinic
Advanced therapy medical products (AMTPs) are medicines for human use that are based on genes, tissues or cells. They offer groundbreaking new opportunities for the treatment of disease and injury but to bring AMTPs into the clinic is a huge challenge. Complex manufacturing processes, implementation of Good Manufacturing Practices (GMP) specifically for cell and gene products, complex trial designs and regulatory requirements are just a few of the difficulties AMTP developers have to deal with. The BIH is offering a workshop where you have the unique opportunity to learn more about those difficulties and how to overcome them. A small group of selected participants will spend a day with three speakers from different areas (quality risk management in ATMP development, IMPD preparation preparation for ATMPs, Crispr/Cas technology) on learning how to bring ATMPs into the clinic.
Agenda
9:00 – 11:00 am Dr. Gabriele Dallmann, Biopharma Excellence Munich, "IMPD preparation for ATMPs"
11:00 am – 1:00 pm Dr. Markus Hofmann, Hofmann Consulting, "Quality Risk Management in ATMP development"
1:00 – 3:00 pm Working Lunch
3:00 – 5:00 pm Shaun Stapleton, PhD, Rapport Global Strategic Services, "Planning a pre-ID meeting with the FDA"
The course is free of charge and open to BIH, Charité and MDC employees. It is limited to 20 attendees to provide a comfortable learning experience and allow for personalized interactions between the trainers and attendees.
Registration is kindly requested!