Assuring Data Quality and Validity in Clinical Trials for Regulatory Decision Making Workshop Report (1999) / Chapter Skim
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Pages 59-67
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59 APPENDIX C Workshop Registrants Susan Alpert, M.D., Ph.D. Director of Device Evaluation Center for Devices and Radiological Health Food and Drug Administration Margaret Anderson, M.A.
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ASSURING DATA QUALITY AND VALIDITY IN CLINICAL TRIALS60 Suanna Bruinooge Legislative Assistant to The Honorable Nancy Johnson U.S. House of Representatives Bruce Burlington, M.D.
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APPENDIX C 61 Elizabeth D'Angelo Assistant Director, International GCP Group Manager, CQA European Pharmaceuticals Zeneca Pharmaceuticals Nancy Davidan Senior Scientist Office of Research Integrity U.S. Department of Health and Human Services Barbara Davies Regulatory Affairs Associate Pro-Neuron, Inc.
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ASSURING DATA QUALITY AND VALIDITY IN CLINICAL TRIALS62 Armand Girard Clinical Project Manager Pro-Neuron, Inc. Paul Gittelson President BioResearch Monitors, Inc.
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APPENDIX C 63 Thomas Kirsch Executive Director, Regulatory Practices The R.W. Johnson PRI Charma Konnor Director Bioresearch Monitoring Division Office of Compliance, Center for Devices and Radiological Health Food and Drug Administration Todd Koser Senior Database Analyst Janssen Research Foundation Judith Kramer, M.D.
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ASSURING DATA QUALITY AND VALIDITY IN CLINICAL TRIALS64 Theresa McGovern, Esq. Executive Director HIV Law Project Samuel Merrill, Jr.
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APPENDIX C 65 Nicholas Pelliccione, Ph.D. Senior Director Worldwide Regulatory Affairs Schering Plough Sandy Phelan Director, Regulatory Affairs Animal Health Institute Jim Phillips, Ph.D.
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ASSURING DATA QUALITY AND VALIDITY IN CLINICAL TRIALS66 Caryn Steakley, R.N. Director Research Nursing and Clinical Operations Georgetown University Medical Center Gail Stoner Manager, Clinical Research Programming Centocor, Inc.
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APPENDIX C 67 Sumner Yaffe, M.D. Director, Center for Research for Mothers and Children National Institute of Child Health and Human Development National Institutes of Health Kathryn Zoon, Ph.D.
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