Institute for International Research

This page will be used to provide paid delegates of the conference with access to any presentations that were not included in the conference documentation. Only paid conference delegates have permission to access IIR online documentation.

While these presentations were not available to be included in your conference documentation, IIR is pleased to make them available to all conference delegates through this web site.

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

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’s Office, FDA

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

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

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
Peggy Schrammel, Executive Director, Late Phase Development, PHARMANET DEVELOPMENT GROUP

Post Approval Studies to Assess Product Safety and Identify Potential Risk
Songlin Xue, MD, PhD, Vice President and Global Head of Epidemiology, NOVARTIS PHARMACEUTICALS

Data Mining in Post Approval Studies to Detect Signals Early
Sheila Weiss Smith, PhD, FISPE, Associate Professor, UNIVERSITY OF MARYLAND