Aims: This half-day provides a comprehensive exploration of Advanced Therapy Medicinal Products (ATMPs) and their regulatory framework. Participants will gain insights into the historical context of ATMP regulations and classifications, as well as delve into topics such as Good Clinical Practice (GCP), safety considerations, CAR T (Chimeric Antigen Receptor T cell)mechanism of action and viral vectors. The course also focuses on Good Manufacturing Practice (GMP) for ATMPs, covering key considerations, manufacturing processes, and quality control, ultimately allowing participants to gain an understanding in the dynamic field of advanced therapies in the context of clinical trials.
Speakers:
Alison Evans (Regulatory Manager – ATMPs, UCL)
Michelle Quaye (Regulatory Manager –ATMPs, UCL)
Yusuf Jaami (Regulatory Manager –Pharmaceuticals, UCL)
Juliana Dias Alves Pinto (Lead CAR T GMP Production, Royal Free)
Bilyana Popova (Senior Trial coordinator Advanced Therapies group, UCL)
Alex Day (Senior Trial coordinator Advanced Therapies group, UCL)