Spiros Vamvakas, MD, is the Scientific Lead/Scientific Adviser on Human Medicines at the European Medicines Agency and serves on the EMA core team for COVID-19 products and guidelines. He joined the EMA in 1999, where he was responsible for establishing the orphan drug designation and had roles in scientific advice/protocol assistance for the qualification of novel methodologies, and as an advisor to health technology assessment organizations and payers. Between 2003 and 2016 Dr. Vamvakas represented EMA in ICH, serving as EMA Coordinator, as a member of the Management Committee, and as leader of the New Topics Subcommittee.

Dr. Vamvakas received his medical degree at the University of Würzburg, Germany, and is a board-certified specialist in pharmacology and toxicology from the Bavarian Chamber of Physicians. He has an active teaching appointment at the University Clinic of Würzburg in the Department of Pharmacology and Toxicology and formerly taught at the University of Rochester Medical Center. Since 2019 he has been an associate editor of the journal Clinical Pharmacology and Therapeutics.