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Nov 18, 2013 11:00 AM - Nov 18, 2013 12:30 PM

Online

Practical Aspects and Examples of Using Large Datasets for Investigating Product Safety and Effectiveness in the US and EU

Speakers

Mary  Mease, MPH, RPh

Mary Mease, MPH, RPh

PV and Risk Management Strategy and Operations, Consultant, United States

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.

Suzanne L West

Suzanne L West

Fellow and Senior Scientist, Social Policy, Health & Economics Research, RTI International, United States

Nancy A Dreyer, PhD, MPH, FISPE

Nancy A Dreyer, PhD, MPH, FISPE

Founder, Dreyer Strategies LLC, United States

Nancy Dreyer is Chief Scientific Advisor to Picnic Health and Adjunct Professor of Epidemiology at the University of North Carolina. Recently retired from full-time employment as Chief Scientific Officer at IQVIA Real World Solutions, she maintains an active career consulting, publishing and teaching for the International Society of Pharmacoepidemiology (ISPE). She is a Fellow of DIA and a member of DIA's Scientific and Policy Advisory Council, a Fellow of the International Society for Pharmacoepidemiology and a member of the ISPOR RWE leadership team. She has helped advance global use of real-world evidence by medicinal product regulators, with her work cited in guidelines in the US, Europe, and China.

Susana  Perez-Gutthann, MD, PhD, MPH, FISPE, FRCP

Susana Perez-Gutthann, MD, PhD, MPH, FISPE, FRCP

Vice President, Global Head Epidemiology, RTI Health Solutions, Spain

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.

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