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Reference Safety Information

Better understand basic aspects of the EU Regulation and Guidance that govern the content, placement, use, and management of the Reference Safety Information for assessing expectedness and causality to determine reportability of individual clinical trial cases.


Krisztina L. Debreczeni, MD

Krisztina L. Debreczeni, MD

Head, Medical Safety Review and Expedited Safety Reporting, Bristol Myers Squibb Co., United States

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.

Stephen  Knowles, MD, MRCP

Stephen Knowles, MD, MRCP

Chief Medical Officer, Halozyme Therapeutics, United States

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  Lipetz, MD, PhD, MBA, MSc

Kenneth Lipetz, MD, PhD, MBA, MSc

Associate Director, PV Ops – PM, Moderna, United States

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.