Dr Krystyna Cegielska-Perun, PhD, has been working at the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products since 2017, and since 2021 has served as Head of the Unit for the Assessment of Documentation Regarding the Safety of Medicinal Products. Since 2022, she has been a member of the editorial team of the Almanach, the journal of the Office. She is an expert in several international pharmacovigilance working groups. She is also a member of the Polish Society of Pharmacovigilance (PTBFarm) and, since 2024, the International Society of Pharmacovigilance (ISoP).

Jamie Wilkins, Pharm.D. is an experienced pharmacist and former regulator currently responsible for partnering with internal and external stakeholders on delivering innovative, strategic global safety and risk management excellence for Pfizer’s drug and biologics portfolio. Prior to her role at Pfizer, Jamie served as the Deputy Director for the Division of Risk Management (DRM) at the US FDA. She is a two-time recipient of the FDA Francis O. Kelsey drug safety award, and has a deep passion for safety, and risk management science.

Ryan has over 10 years’ experience in the field of patient safety and medicines development, in both CRO and big pharma environments, encompassing clinical and post-marketing products across a broad range of therapeutic areas. Most recently, Ryan has specialised in risk management implementation, successfully leading and coordinating complex global risk management strategies including digital elements to plan.

Mark is a founder and managing partner at Axian Consulting, where he focuses on improving benefit-risk balance and outcomes for patients through improving communication and adding value using digital approaches. He has a >20 year pharma career which has included industry (Wellcome, GW, GSK and AZ) and consultancy roles (WCI, Foresight, PopeWoodhead, Huron and now is a founder and managing partner of Axian Consulting). He is now focusing on the opportunities presented by improved benefit-risk management approaches to enhance risk management decision-making in development and on adding value to the interactions of industry and customers to maximise B-R balance and improve outcomes in REMS and aRMM programmes.

Meredith is a health services and implementation science researcher with + 20 yrs of experience in the pharmaceutical industry where she has held senior positions in drug safety, health economics and regulatory affairs. Currently, she is a Fellow of the Int. Society for Pharmacoepidemiology, and a faculty member at the Alfred E. Mann School of Pharmacy & Pharmaceutical Sciences at the University of Southern California. Meredith has been an invited participant in numerous risk management workshops and panels sponsored by the US FDA, and has served as a member of CIOMS IX Practical Approaches to Risk Minimisation for Medicinal Products, CIOMS XI Patient Involvement in the Development and Safe Use of Medicines and IMI-PREFER.