DR Michel Mikhail | Expert in Global Regulatory Affairs and Governmental relations, Expert in Biosimilars
Independent

Dr. Michel Mikhail has more than 30 years Pharmaceutical Industry experience and track record of achievement in R & D and International Regulatory Affairs in large multinational Research-based pharmaceutical Companies as well as Generic & Biosimilars companies. He also has global experience and significant contribution in Biotech industry. Dr. Mikhail is a global expert in Regulatory Affairs and International Expert in Biosimilars. He is a Chartered Expert in Pharmacology-Toxicology, a chartered Clinical Expert and a chartered Analytical Expert. Dr Mikhail served on the European Biosimilars Group, the Regulatory and Scientific Affairs Group of the European Generic medicines Association (EGA) now Medicines for Europe, as well as on different associations and organizations. He also served on the Safety working group and Efficacy working Group of the European Federation of pharmaceutical Industry associations (EFPIA) also as a Topic Leader for new Guidelines. He served on the Regulatory Group of the European branch of the Pharmaceutical Research and Manufacturers of America (PhRMA Europe). Dr. Mikhail served as member of the Expert committee of the Governmental Federal Institute of Risk Assessment (BfR) Berlin, Germany and served as member of the Expert Committee for Toxicology of the United States Pharmacopoeia (USP), Bethesda, USA.