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 brings her experience as Chief Scientific Officer at IQVIA Real World Solutions and SVP roles at IQVIA, Quintiles, Outcome Sciences Inc and UnitedHealth Group to independent consultancy. Her work focuses on advancing the use of real-world evidence for safety, effectiveness and natural history research, using diverse forms of data including patient-generated health data, electronic medical records, medical and pharmacy claims, data linkage and data integration. She is a Fellow of International Society of Pharmacoepidemiology (ISPE) and of DIA, and is a Science and Policy Advisor to DIA, Adjunct Professor of Epidemiology at the Univ of North Carolina at Chapel Hill and a member of 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.