Appendix A
Workshop Agenda
INSTITUTE OF MEDICINE
National Academy of Sciences
ROUNDTABLE ON RESEARCH AND DEVELOPMENT OF DRUGS, BIOLOGICS, AND MEDICAL DEVICES
Assuring Data Quality and Validity in Clinical Trials for Regulatory Decision-Making
April 14–15, 1998
National Academy of Sciences Auditorium
2101 Constitution Avenue, N.W., Washington, D.C.
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TUESDAY, APRIL 14: DAY ONE |
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OPENING PLENARY |
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8:30 a.m. |
Welcome Kenneth Shine, M.D. President, Institute of Medicine |
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Opening Statement, Charge to Participants Ronald Estabrook, Ph.D., Roundtable Chair Virginia Lazenby O'Hara Professor of Biochemistry University of Texas Southwestern Medical Center |
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8:45 a.m. |
Overview of Issues Janet Woodcock, M.D. Director, Center for Drug Evaluation and Research Food and Drug Administration |
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SESSION I: PRESUBMISSION |
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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 |
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9:30 a.m. |
Questions and Answers |
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9:45 a.m. |
Monitoring Eleanor Segal, M.D. Senior Director for Drug Safety and Clinical Quality Assurance Chiron Corporation |
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10:15 a.m. |
Michaele Christian, M.D. Associate Director, Cancer Therapy Evaluation Program National Cancer Institute, National Institutes of Health |
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10:45 a.m. |
Questions and Answers |
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11:00 a.m. |
BREAK |
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11:15 a.m. |
Data Handling and Clean-up Kristin O'Connor, M.P.H. Director, Data Management Boehringer Ingleheim Pharmaceuticals, Inc. |
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11:45 a.m. |
Questions and Answers |
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12:00 p.m. |
LUNCH |
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SESSION II: FDA SUBMISSION |
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1:30 p.m. |
Preparation and Content of Marketing Applications Nicholas Pelliccione, Ph.D. Senior Director, Worldwide Regulatory Affairs Schering Plough |
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2:00 p.m. |
Questions and Answers |
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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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Panelists: Robert Califf, M.D. Duke Clinical Research Institute |
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Michaele Christian, M.D. National Cancer Institute, National Institutes of Health |
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Susan Ellenberg, Ph.D. Center for Biologic Evaluation and Research Food and Drug Administration |
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Frank Hurley, Ph.D. Quintiles Transnational Corporation |
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Kiyoshi Kuromiya Critical Path AIDS Project |
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David Lepay, M.D., Ph.D. Center for Drugs Evaluation and Research Food and Drug Administration |
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Mike McGarvey, M.D. Blue Cross/Blue Shield of New Jersey |
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Kristin O'Connor, M.P.H. Boehringer Ingleheim Pharmaceuticals, Inc. |
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Nicholas Pelliccione, Ph.D. Schering Plough |
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John R. Schultz, M.D. University of Virginia |
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Eleanor Segal, M.D. Chiron Corporation |
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3:45 p.m. |
BREAK |
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4:00 p.m. |
Plenary Review of the Day, Discussion of Issues, and Plans for Tomorrow |
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Michael Clayman, M.D. Vice President, Cardiovascular Research and Clinical Investigations, Lilly Research Laboratories, Eli Lilly and Company |
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5:00 p.m. |
ADJOURN, RECEPTION |
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WEDNESDAY, APRIL 15: DAY TWO |
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SESSION III: FDA REGULATORY REVIEW |
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8:30 a.m. |
FDA Review: Paper Auditing Jay P. Siegel, M.D. Director, Office of Therapeutics Research and Review Center for Biologic Evaluation and Research Food and Drug Administration |
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9:00 a.m. |
FDA Clinical Site Review and IRB Audit David Lepay, M.D., Ph.D. Director, Division of Scientific Investigations Center for Drug Evaluation and Research Food and Drug Administration |
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9:30 a.m. |
Questions and Answers |
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9:45 a.m. |
BREAK |
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10:00 a.m. |
Sanctions Stan Woollen Deputy Director, Division of Scientific Investigations Center for Drug Evaluation and Research Food and Drug Administration |
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10:15 a.m. |
Assessment Murray Lumpkin, M.D. Deputy Director for Review Management Center for Drug Evaluation and Research Food and Drug Administration |
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10:45 a.m. |
Susan Alpert, M.D., Ph.D. Director, Office of Device Evaluation Center for Devices and Radiological Health Food and Drug Administration |
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11:15 a.m. |
Questions and Answers |
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11:30 a.m. |
LUNCH |
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1:00 p.m. |
Panel Discussion II: FDA Review Moderator: Whaijen Soo, M.D. Ph.D. Vice President, Clinical Sciences Hoffmann-La Roche, Inc. |
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Panelists: |
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Susan Alpert, M.D., Ph.D. Center for Devices and Radiological Health Food and Drug Administration |
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William Fairweather, Ph.D. Office of Epidemiology and Biostatistics Food and Drug Administration |
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Charma Konnor Center for Devices and Radiological Health Food and Drug Administration |
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Robert Levy, M.D. Wyeth-Ayerst Research |
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Murray Lumpkin, M.D. Center for Drugs Evaluation and Research Food and Drug Administration |
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Roger Meyer, Ph.D. American Association of Medical Colleges |
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Jay Siegel, M.D. Center for Biologics Evaluation and Research Food and Drug Administration |
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Frances Visco, J.D. National Breast Cancer Coalition |
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William Waggoner, Ph.D. Essex Institution Review Board |
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Stan Woollen Center for Drugs Evaluation and Research Food and Drug Administration |
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2:30 p.m. |
Wrap-up Discussion Janet Woodcock, M.D. Director, Center for Drug Evaluation and Research Food and Drug Administration |
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Ronald Estabrook, Ph.D. Roundtable Chair |
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Virginia Lazenby O'Hara Professor of Biochemistry University of Texas Southwestern Medical Center |
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3:30 p.m. |
ADJOURN |
