Michel Mikhail
Dr
International Expert in Global Regulatory Affairs
Germany
Biography
Dr. Dr. Michel Mikhail has more than 25 years Pharmaceutical Industry experience and track record of achievement in R & D and International Regulatory Affairs in large multinational Research-based pharmaceutical Companies, Biotech Companies as well as in the Generic industry. Dr Mikhail is an Expert in Biosimilars. Has been involved in the Global Development and Worldwide regulatory approval of Blockbuster Medicines He was involved in shaping the EU Biosimilars Guidelines and their Review, the WHO Guidelines, Other ICH Guidelines and now in the US-FDA Biosimilars Guidelines. He is a Chartered Expert in Pharmacology -Toxicology, a chartered Clinical Expert as well as a chartered Analytical Expert. Dr Mikhail served on the Safety working group and Efficacy working Group 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), on the European Biosimilars Group, the Regulatory and Scientific Affairs Group of the European Generic medicines Association (EGA), as well as on different associations and organizations. Dr Mikhail is member of the Expert committee of the Government Federal Institute of Risk Assessment (BfR) Germany. and served as member of the Expert Committee for Toxicology of the United States Pharmacopoeia
Research Interest
Dr. Michel Mikhail’s area of expertise is Non-Clinical Pharmacology and Toxicology as well as Global regulatory Affairs and Regulatory Agencies Interaction. In particular interaction with the US-FDA, the EU_EMA as well as National Agencies in Europe such as UK-MHRA, German BfArM and PEI, France’s ANSM, Sweden’s MPA, among others, interaction with Japan’s PMDA and Emerging markets Agencies. Dr. Michel Mikhail is an Expert in Biosimilars. He is Interested in Immuno-Oncology, Regenerative Medicine, in vitro and in vivo Animal modeling, and mechanisms of Action associated with diseases and regenerative medicine.