SESSION I: PRESUBMISSION

9:00 a.m.

Data Collection

John R. Schultz, Ph.D.

Vice President and General Manager, Neuroclinical Trials Center

Virginia Neurological Institute, University of Virginia

9:30 a.m.

Questions and Answers

9:45 a.m.

Monitoring

Eleanor Segal, M.D.

Senior Director for Drug Safety and Clinical Quality Assurance

Chiron Corporation

10:15 a.m.

Michaele Christian, M.D.

Associate Director, Cancer Therapy Evaluation Program

National Cancer Institute, National Institutes of Health

10:45 a.m.

Questions and Answers

11:00 a.m.

BREAK

11:15 a.m.

Data Handling and Clean-up

Kristin O'Connor, M.P.H.

Director, Data Management

Boehringer Ingleheim Pharmaceuticals, Inc.

11:45 a.m.

Questions and Answers

12:00 p.m.

LUNCH

SESSION II: FDA SUBMISSION

1:30 p.m.

Preparation and Content of Marketing Applications

Nicholas Pelliccione, Ph.D.

Senior Director, Worldwide Regulatory Affairs

Schering Plough

2:00 p.m.

Questions and Answers

2:15 p.m.

Panel Discussion I: Presubmission and Submission

Moderator: Susan Alpert, M.D., Ph.D.

Center for Devices and Radiological Health

Food and Drug Administration



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