Steve received his MD from the University of Newcastle Upon Tyne, UK and worked in the UK National Health Service for 17 yrs. He joined Halozyme in 2018 as Vice President, Drug Safety & Pharmacovigilance and became Chief Medical Officer in January 2020, with responsibility for Drug Safety, Medical and Regulatory. Prior to this, Steve worked at Eli Lilly for 16 years, 12 years of which was in drug safety in various roles of increasing responsibility involving safety operations and drug safety surveillance

Kenneth J Lipetz, PhD, MBA, HCLD is currently the Associate Director, PV Ops – PM at Moderna, Inc. Prior to joining Moderna, he had been with Eli Lilly and Company for over 23 years, Ken has had a number of key strategic, technical and administrative roles in Clinical PM, Clinical Data Management, Data Privacy, Drug Safety, Pharmacovigilance and Drug Development. Ken is also a Certified Lean/Six Sigma Black Belt working on multiple process improvement projects.

Krisztina has been working at BMS for 15 years. In the past eight years, she has been leading a team of physicians responsible for the medical assessment of ICSRs as well as a team of scientists responsible for the preparation of expedited safety reports. Krisztina also oversees the Company's large ICSR processing outsourcing operation for medical review and expedited safety reporting. Krisztina has been serving as a subject matter expert on Reference Safety Information for several years, working closely with internal and external experts on this topic.

Dr. Elena Prokofyeva is head of drug safety unit at the Department of Research & Development, DG PRE, the FAMHP, Brussels, Belgium. She represents Belgium within the CTFG safety subgroup. She initiated and led an update of the Q&A-RSI document within the CTFG. Dr. Prokofyeva holds a research doctorate from the University of Tuebingen, Germany, a Ph.D. and an M.D. from the Northern State Medical University, Arkhangelsk, Russia, and a Master of Public Health from the University of Umeå, Sweden. Harmonization of safety assessment across members of states in Europe, preparation for the implementation of a safety related part of clinical trial regulation, and safeguarding the safety of trial participants are main objectives of her work.