Institute for International Research

Recap from Chairperson

Songlin Xue, MD PhD, Vice President and Global Head of Epidemiology, NOVARTIS PHARMACEUTICALS

Taking a Page Out of Lifecycle Management’s Book: Focusing on Post-Approval Risk Management at an Earlier Stage.

Annette Stemhagen, Dr.PH., FISPE, Vice President, Epidemiology and Risk Management, UNITED BIOSOURCE CORPORATION

Keynote Session: The Future of Risk Management: Active Safety Surveillance Programs to Mitigate Risk

Mark McClellan, MPA, MD, PHD, Director of the Engelberg Center for Healthcare Reform, BROOKINGS INSTITUTE, Administrator, CENTERS FOR MEDICARE & MEDICAID SERVICES (2004-2006) and Commissioner, FDA (2002-2004)

Featured Session: Increasing Pharmaceutical Safety Using Electronic Health Records

Michael A. Ibara, Head of Pharmacovigilance Information Management, PFIZER

Post Approval Studies to Assess Product Safety and Identify Potential Risk

Songlin Xue, MD, PhD, Vice President and Global Head Clinical Epidemiology, NOVARTIS PHARMACEUTICALS

Data Mining in Post Approval Studies to Detect Signals Early

Sheila Weiss Smith, PhD, FISPE, Associate Professor, UNIVERSITY OF MARYLAND

Determining the Need for a RiskMAP: Calculating the Benefi t/Risk Balance

Meredith Y. Smith, PhD, MPA, Director, Risk Management & Health Policy, PURDUE PHARMA LP

Panel Discussion: Measuring the Impact of Risk Minimization Plans

Vikram Dev, Vice President and Head of Drug Safety, ASTRAZENECA US 

John Ferguson, Vice President Global Head of Pharmacovigilence and Medical Safety, NOVARTIS

Nayan Nanavati, Vice President, Peri-Approval Clinical Excellence (PACE), North America, PARAXEL INTERNATIONAL

John J. Seman, Executive Director, THE LIFEWATCH INSTITUTE

Conference Concludes