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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  Dreyer, PhD, MPH, FISPE

Nancy Dreyer, PhD, MPH, FISPE

Founder, Dreyer Strategies LLC, United States

Nancy Dreyer is Chief of the Scientific Advisory Board at OM1, and brings her experience having served as Chief Scientific Officer at IQVIA Real World Solutions, Global Chief of Scientific Affairs at Outcome Sciences and Quintiles, and CEO of Epidemiology Resources Inc. Her expertise includes patient-generated information, electronic health records, health insurance claims, and data linkage, including collaboration with regulators and HTA. Widely published, she is a Science and Policy Advisor to DIA and a member of the Real-World Evidence Leadership Team for ISPOR. She is a Fellow of ISPE and DIA, an Adjunct Professor of Epidemiology at University of North Carolina at Chapel Hill and a Trustee of Brandeis University.

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

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

SR. VP, Global Lead Regulatory Rwe/Epidemiology & Biostatistics, Research Triangle Institute, 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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