On Demand Content Preview Webinar - When Is Real World Evidence Ready for Prime Time Encore Presentation
Nancy A. Dreyer, PhD, MPH, FISPE
- Chief Scientific Officer and Senior Vice President
- IQVIA, United States
Nancy Dreyer is Chief Scientific Officer and SVP at IQVIA and Adjunct Professor of Epidemiology at the U of N Carolina School of Global Public Health. She leads the IQVIA Center for Advanced Evidence Generation. A fellow of both the International Society for Pharmacoepidemiology and DIA, her current work is focused on COVID-19 along with other issues of regulatory and public health importance. Recent recognition includes the Red Jacket honor from PharmaVOICE in 2020 and DIA’s Global Inspire Award for Author of the Year in 2019. She is also celebrating recent publication of the 4th edition of the popular book “Registries for Evaluating Patient Outcomes: a User’s Guide.”
Solomon Iyasu, DrMed, MPH
- Vice President and Head of Pharmacoepidemiology
- Merck & Co., Inc., United States
Dr. Iyasu joined Merck and Co. in August of 2015 as head of Pharmacoepidemiology in the Center for Observational and Real-World Evidence (CORE). In his current role, he leads a department that is responsible for designing and conducting postapproval observational safety and effectiveness studies (PASS/PAERs), real-world data analytics to characterize disease epidemiology, inform early development, clinical trial design and endpoint strategy (selection, validation of PROs and clinical outcomes, biomarkers).
Peter P. Stein, MD
- Director, Office of New Drugs, CDER
- FDA, United States
Peter Stein, M.D., is the Director of CDER’s Office of New Drugs (OND). OND is responsible for the regulatory oversight of investigational studies during drug development and decisions regarding marketing approval for new (innovator or non-generic) drugs, including decisions related to changes to already marketed products. OND provides guidance to regulated industry on a wide variety of clinical, scientific, and regulatory matters.
Anthony Humphreys, MPharm
- Head of the Regulatory Science and Innovation Task Force
- European Medicines Agency, Netherlands
He is the Head of the Regulatory Science and Innovation Task Force (TRS). He is responsible for providing leadership in the taskforce and the Agency to enable it’s continuous future proofing through operation of a regulatory science observatory, addressing key scientific and technological trends and their translation through the development of regulatory science strategy, planning and governance.