Institute for International Research

Welcome from Chairperson

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

Keynote Address: The Public Perception of the Pharmaceutical Industry and Drug Safety: Implications on the Culture of Safety

Matthew Whalen, PhD, Vice President, THE PHARMACEUTICAL SAFETY INSTITUTE

The Impact of the FDA Amendments Act Drug Safety Provisions on the Pharmaceutical Industry

Arnold Friede, Practicing Food and Drug Law Attorney, Former Associate Chief Counsel, Chief Counsel’s Offi ce, FDA

EXCLUSIVE INVITE-ONLY EXECUTIVE TASK FORCE REPORT: The Industry’s Guide to Risk Management and Adapting in the Changing Regulatory Environment: Brought to You by the Executive Task Force

Led By:
Peggy Schrammel, Executive Director, Late Phase Development, PHARMANET, INC

Summit Panel
Carmen Bozic, Vice President of Drug Safety and Risk Management, BIOGEN IDEC

Paul Coplan, Sc.D., MBA, MPH, Senior Director, Risk Management, Global Safety, Surveillance, Epidemiology and Labeling, WYETH RESEARCH

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

J. David Haddox, DDS, MD, Vice President, Risk Management and Health Policy, PURDUE PHARMA LP

Mary Frances Schubert, Director in Clinical Risk Management and Safety Surveillance, MERCK

Meeting the Challenges of Risk Management on a Global Level

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

Featured Session: Navigating the Regulatory Burden of Global Companies: A Side-by-Side Comparison of the Risk Management Regimes of the FDA, EMEA and MHLW

Christopher-Paul Milne, DVM, MPH, JD, Associate Director, TUFTS CENTER FOR THE STUDY OF DRUG DEVEOPMENT

Payer Perspective: The End User Part of the Equation: Developing the Outcome Research Required for Managed Care Institutes around Patient Safety and Efficacy

Saira A. Jan, MS, Pharm D, Director for Clinical Pharmacy Management, HORIZON BLUE CROSS BLUE SHIELD NJ, Associate Professor, RUTGERS STATE UNIVERSITY OF NEW JERSEY

Optimally Leveraging Epidemiologic and Observational Studies in the Development of an Appropriate RiskMAP or REMS

Jeffrey J. Stoddard, MD, FAAP, Vice President, Medical and Scientific Affairs, Risk Management and Post Marketing Programs, COVANCE

A Case Study on Drugs Containing a Controlled Substance: Real-Life Pharmaceutical Risk Management-The OxyContin® Story

J. David Haddox, DDS, MD, Vice President, Risk Management & Health Policy, PURDUE PHARMA LP