2008 FDA/Industry Conference

Our May 6 FDA/Industry Conference was a great success.
We thank all of our speakers for presenting such outstanding talks, our panelists for coming up with insightful questions, and our moderators for overseeing the sessions.

We also thank our audience for attending and adding to the dialogue that ensued throughout the day.

We hope to see you at our next event in 2010.

PowerPoint Presentations from
Temple University School of Pharmacy QA/RA Graduate Program
FDA/Industry Conference
Tuesday, May 6, 2008

FDA and Industry Today: Update from the FDA and Industry on current trends and concerns

Janet Woodcock, MD, Director, Center for Drug Evaluation and Research, FDA
Thomas Koestler, PhD, President, Schering-Plough Research Institute

PDUFA IV: What Should We Expect?
Sandra Kweder, MD, Deputy Director, Office of New Drugs, CDER
D. Bruce Burlington, MD, Independent Consultant, Boothwyn, PA

GMPs for the 21st Century
Joseph C. Famulare, Deputy Director, Office of Compliance, CDER
Ferdinando Aspesi, Senior Vice President of Global Quality and Compliance, Wyeth Pharmaceuticals

Enhancing Positive Perceptions of the Industry through Education
Andrew Clair, PhD, Director, Worldwide Neuroscience, Pfizer Inc

Adaptive Trial Design
Robert J. Temple, MD, Associate Director for Medical Policy, CDER
José Carlos Pinheiro, PhD, Senior Biometrical Fellow, Novartis Pharmaceuticals

Genomics (Critical Path)
Lawrence J. Lesko, PhD, Director, Office of Clinical Pharmacology, CDER
Daniel K. Burns, PhD, Senior Vice President, Pharmacogenetics, GlaxoSmithKline

Safety of Pharmaceutical Ingredients
Richard L. Friedman, MS, Director, Office of Compliance, Division of Manufacturing and Product Quality, CDER
David R. Schoneker, Director of Global Regulatory Affairs, Colorcon, and Chair of IPEC Americas

Drug Safety/Post Marketing Safety: Where are we going? (REMs, IOMs)
Jane A. Axelrad, JD, Associate Director, Office of Regulatory Policy, CDER
Adrian Thomas, MD, FRACP, Global Head, Benefit-Risk Management & Chief Safety Officer, Johnson & Johnson Pharmaceutical Group
Martha Brumfield, PhD, Senior Vice President of Worldwide Regulatory Affairs and Quality Assurance, Pfizer Inc

Our May 6 FDA/Industry Conference was a great success. We thank all of our speakers for presenting such outstanding talks, our panelists for coming up with insightful questions, and our moderators for overseeing the sessions.

We also thank our audience for attending and adding to the dialogue that ensued throughout the day.

We hope to see you at our next event in 2010.

Our May 6 FDA/Industry Conference was a great success.
We thank all of our speakers for presenting such outstanding talks, our panelists for coming up with insightful questions, and our moderators for overseeing the sessions.