Dr. Michel Mikhail has more than 25 years Pharmaceutical Industry experience in Senior roles in R & D and International Regulatory Affairs in large multinational pharmaceutical companies. Dr Mikhail is a Chartered Expert in Pharmacology -Toxicology, a chartered Clinical Expert as well as a chartered Analytical Expert. Dr Mikhail served and continue to serve on many Expert panels such as the USP (US Pharmacopea’s Council of Experts - Toxicology Expert Committee), He is elected member of the Commision for Risk Assessment of Federal Institute for Risk Assessment (BfR) Berlin,. He is member of the Drug Information Association - DIA - as a volunteer contributor.
Dr Mikhail served on the Safety and Efficacy working Groups of the European Federation of pharmaceutical Industry associations (EFPIA) also as a Topic leader. He served on the Regulatory Group of the European branch of the Pharmaceutical Research and Manufacturers of America (PhRMA Europe). He served as member of the Regulatory and Scientific Affairs Group, the European Biosimilars Group, the Executive Committee and the Board of the European Generic Medicines Association (EGA), as well as on different associations and organizations. Since the 80s, he became member of the British Institute of Regulatory Affairs (BIRA), the European Society of Regulatory Affairs (ESRA), both now became The Organisation for Professionals in Regulatory Affairs (TOPRA).