Michael Dr Jandke

EU Head of Regulatory Affairs and registered pharmacist with over 20 years of experience in Global Regulatory Affairs in biopharmaceuticals and generics. Regular speaker and trainer for Cell & Gene products and Biologics (e.g. Monoclonal Antibodies) at Forum Institute, Germany. Focus on biologics-ATMPs, oncology, autoimmune and orphan diseases. Responsible for pharmaceutical approval processes e.g. EU. Managing collaboration with authorities and steering the approval process to obtain clinical trial authorisation(s) and market approval. Providing guidance to several stakeholder (incl. risk management for ATMPs) anticipating regulatory obstacles and managing the approval process for ATMPs. Contributed to the Marketing Authorisation for: Spherox(R) (ATMP, Tissue Engineered Product) Cell&Gene therapy: CAR-T development in several indications - MAA process and IND/IMPD filings EU and US as well as driving the IND process in Japan with PMDA.