Dr. Michel Mikhail will be an exclusive chairman of this online conference. Dr. Michel Mikhail has more than 25 years of pharmaceutical industry experience and a 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. He was involved in shaping the EU Biosimilars Guidelines and their review, the WHO Guidelines, other biosimilars guidelines around the world and now the US-FDA Guidelines. He is a chartered expert in pharmacology-toxicology, a chartered clinical expert as well as a chartered analytical expert. Dr. Mikhail also served on the safety working group and efficacy working group of the European Federation of Pharmaceutical Industry Associations (EFPIA) as a topic leader. He served in 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 in various other associations and organizations. Dr. Mikhail served as a member of the expert committee for toxicology of the United States Pharmacopoeia (USP) and is a member of the expert committee of the Government Federal Institute of Risk Assessment (BfR), Germany.