Dr. Meredith Smith is a behavioral scientist and health services researcher by training with over 15 years of professional experience in the pharmaceutical industry in the areas of health outcomes research, health policy, drug safety, and risk management. In her current role as Director of Risk Management at Alexion Inc., she oversees a state-of-the-art risk management monitoring system, and is building capacity for digital risk minimization measures, structured benefit-risk assessment, and patient-centered approaches to risk management.
In terms of professional service, Dr. Smith has been an invited participant in risk management workshops and panels sponsored by the US Food and Drug Administration and has also served as a co-author and co-editor of CIOMS IX, Practical Approaches to Risk Minimisation for Medicinal Products. Since 2018, she has served as Track Chair, Clinical Safety and Pharmacovigilance for the Drug Information Association’s Annual Meeting. She is also currently a member and Case Study Co-Lead of IMI-PREFER, an international working group seeking to develop consensus recommendations on methods for patient preference elicitation for benefit-risk assessment, and a Group Lead in CIOMS XI, Patient Involvement in the Development and Safe Use of Medicines. She has published widely in the peer-reviewed literature with particular focus on topics related to the design, implementation and evaluation of therapeutic risk minimization measures, risk communication and benefit-risk assessment. Dr. Smith’s recent publications focused on the development of a checklist to assess the quality of studies evaluating risk minimization programs entitled the RIMES Statement (Smith et al., Drug Safety, 2018), and a systematic review of the published and gray literature on risk minimization evaluation applying the RIMES Statement (Russell AM et al, Drug Safety, 2020). Tantmieux57@gmail.com