Ms. Mease leads safety and REMS at Quintiles. She served as an expert for 11 yrs at the FDA/CDER on drug benefit risk communication, risk management, and pharmacovigilance and led the establishment of CDER’s Drug Safety Oversight Board. She holds a BS in Pharmacy and a Masters in Public Health.

Nancy Dreyer served as Chief Scientific Officer at IQVIA Real World Solutions, Global Chief of Scientific Affairs at Outcome Sciences Inc and Quintiles, and CEO of Epidemiology Resources Inc. prior to switching to consultancy. She maintains active practice in the biopharmaceutical industry. Her primary research interest is to advance use of RWE including patient-generated health data, electronic medical records, medical and pharmacy claims, data linkage and data integration for studies of safety, effectiveness and natural history. She is a Fellow of ISPE, a Science and Policy Advisor and Fellow of DIA, Adjunct Professor of Epidemiology at the Univ of North Carolina at Chapel Hill and serves on ISPOR's RWE Leadership Team.

Susana Perez-Gutthann, MD, MPH, PhD, FISPE, FRCP, is Vice President, Global Head of Epidemiology at RTI Health Solutions. She leads a team of epidemiologists working in pharmacoepidemiology and risk management research pre and post-approval in Europe and North America. Prior positions include global head of epidemiology at several large R&D pharma companies. She is a Past President of the International Society for Pharmacoepidemiology, and Vice-Chair of the Steering Group of the EMA led European Network of Centers of Pharmacoepidemiology and Pharmacovigilance, ENCePP.