DIA Montreal: June 1997

1. CDER Guidance and Processes for Electronic Regulatory Submissions for Archive: David Isom

2. CDER Transformation Process: Janet Woodcock, M.D.

3. A Collaborative Approach to Drug Development: A New Division's Proactive Processes: Lana L. Pauls, M.P.H.

4. Computers in Clinical Trials Draft Guidance - Implications Stan W. Woollen

5. Computers in Clinical Trials Draft Guidance - Introduction David A. Lepay, MD, PhD

6. The Future of Electronic Submissions: Janet Woodcock, M.D.

7. Progress and Challenges for the U.S. Drug Regulatory System: Janet Woodcock, M.D.

8. A Shift in the Regulatory Approach: Janet Woodcock, M.D.

Last update: July 13, 2005

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