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 Day One

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Agenda: Day 3
Friday, August 26, 2005


Track V: Managing Inspection Risks

8:00 a.m.

Welcome and Introduction

John K. Iglehart
Founding Editor, Health Affairs
National Correspondent, New England Journal of Medicine
Washington, DC

8:15 a.m.

Preparing for the FDA's Risk-Based Inspections

Martin Browning
President, EduQuest
Former FDA Investigator and Special Assistant to the Associate Commissioner for Regulatory Affairs
Food and Drug Administration
Hyattstown, MD

9:15 a.m.

Building a Culture of Compliance and Risk Management

Geoffrey Levitt, Esq.
Vice President and General Counsel
Regulatory and Research, Wyeth Pharmaceuticals
Collegeville, PA

10:15 a.m.


10:30 a.m.

Analysis of Warning Letters: Trends in Enforcement

Steven A. Johnson, Esq.
Vice President and Assistant General Counsel, Allergan
Irvine, CA

Keith M. Korenchuk, J.D., M.P.H.
Partner, McGuireWoods
Washington, DC

Track VI: Managing Risks in Pharmacovigilance

8:00 a.m.

Welcome and Introduction

Robert Barton
Editorial Director, FDA News
Falls Church, VA

8:05 a.m.

Building Quality in Clinical Trials: Avoiding Pitfalls

Michael Marcarelli
Director, Division of Bioresearch Monitoring
Office of Compliance
Center for Devices and Radiological Health (CDRH)
Food and Drug Administration
Rockville, MD

8:35 a.m.

Drug Safety Strengthened by Technology and Data Integrity

Lisa Olson
Principal Consultant, SEC Associates
Research Triangle Park, NC

9:15 a.m.


9:30 a.m.

Best Corporate Practices in Meeting the FDA's Safety Reporting Requirements

Saundra Beacham
Director, Drug Safety Operations
Actelion Pharmaceuticals US
South San Francisco, CA

10:00 a.m.

Best Practices in Meeting Your Postmarketing Study Commitments

Cynthia L. Verst-Brasch, Pharm.D., M.S.
Global Vice President
Late Phase Operating Unit, Kendle
Cincinnati, OH

10:45 a.m.

Risk Management Case Study: The RADARSTM Risk Management Program

J. David Haddox, DDS, MD
Vice President, Risk Management and Health Policy
Purdue Pharma LP
Stamford, CT

Kenneth Hintze
Director, Global Safety and Pharmacovigilance, Kendle
Cincinnati, OH


11:30 a.m.

What We Learned and What We Will Do with This Knowledge

Arthur Miller, Esq.
Bruce Bromley Professor of Law
Harvard Law School
Cambridge, MA

12:15 p.m.

Symposium Adjournment

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