Speakers – Cell & Gene

Julia Djonova, MD is head of the Advanced Therapy Medicinal Products (ATMP) department at Swissmedic, the Swiss Agency for Therapeutic Products. The tasks of the department include all activities with these products from the approval of clinical studies, GMP/GDP/GCP inspections, establishment licenses, market authorizations and market surveillance. Dr Djonova is a medical doctor with clinical experience in cardiology. She worked in research and teaching at the Swiss universities of Lausanne and Freiburg. From 1999 she worked at the Federal Office of Public Health and has been with Swissmedic since 2002, first as a clinical reviewer and then as head of the ATMP department. Dr Djonova is a representative in various national and international forums in the fields of transplants and innovative therapies. She participates in the development of legal requirements in the area of transplants and advanced therapy products as well as in the development of national and international guidelines and a represents the ATMP’s as a pilot project within the Swissmedic Innovation’s office. Dr Djonova is the Swiss representative expert in different international forums, for ex. European Directorate for the Quality of Medicine (EDQM) for the field of Tissues, Cells and Organs, World Health Organization (WHO), International Pharmaceutical Regulators Forum, Cell Therapy Working Group (IPRF), Pharmaceutical Inspection Convention (PIC’s), etc.