The Leading Forum on the Law, Regulation and Ethics of Medical Research in the United States

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The Leading Forum on the Law, Regulation and Ethics of Medical Research in the United States

Fourth National Medical Research Summit

The Leading Forum on the Law, Regulation and Ethics of Medical Research in the United States

April 21 - 23, 2004
Baltimore Waterfront Marriott
Baltimore, MD


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Sponsored By:
American Federation for Medical Research
American Pharmaceutical Review
Applied Clinical Trials
Association of Clinical Research Professionals
BNA's Medical Research Law & Policy Report
CenterWatch Monthly Newsletter
CW Weekly
Clinical Trials Advisor
FDACompliance.Net
FDA News
Georgetown University Medical School
Harvard Health Policy Review
Health Affairs
Human Research Report
International Association of Privacy Professionals
International Journal of Pharmaceutical Medicine
IRB Advisor
IRB Forum
IRB: A Review of Human Subjects Research
Medical Ethics Advisor
Partnership for Human Research Protection
Society for Women's Health Research
The Hastings Center Report
Weill Medical College of Cornell University
National Committee on Quality Assurance
RX Compliance Report


Educational Grantors:











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Keynote Speakers:

Michael Carome, MD
Associate Director for Regulatory Affairs, Office for Human Research Protections, Department of Health and Human Services, Rockville, MD

David Hoffman, Esq.
Assistant U.S. Attorney, Eastern District of Pennsylvania, Philadelphia, PA

Julie A. Kaneshiro
Policy Team Leader, Division of Policy and Assurance, Office for Human Research Protections, Department of Health and Human Services, Rockville, MD

Vanessa King, PhD
Vice President, External Development & Collaborations, The Center for the Advancement of Genomics, Rockville, MD


Summit Co-chairs:

Thomas Puglisi, Ph.D.
Global Pharmaceutical & Health Sciences Group, PricewaterhouseCoopers, Former Director of Human Subject Protections, Office for Human Subjects Research Protections, Washington DC

Michele Russell-Einhorn, JD
Associate General Counsel, J. Craig Venter Science Foundation, Former Director of Regulatory Affairs, Office for Human Research Protection, Department of Health and Human Services, Rockville, MD


Featured Faculty:

Arthur O. Anderson, MD, COL, MC
Chief, Department Clinical Pathology, Office of Human Use and Ethics, US Army Medical Research Institute of Infectious Diseases, Frederick, MD

John Bentivoglio, Esq.
Partner, Arnold and Porter, Former Special Counsel for Healthcare Fraud, Chief Privacy Officer, United States Department of Justice, Washington, DC

Barry B. Bercu, MD
Chair, USF Biomedical IRB, Professor of Pediatrics, Biochemistry and Molecular Biology, Pharmacology and Therapeutics, University of South Florida, College of Medicine, Tampa, FL

Jerry Castellano, PharmD, CIP
Corporate Director, Institutional Review Board, Christiana Care Health System, Wilmington, DE

Gary Chadwick, PharmD, MPH, CIP
Director, Office for Human Subject Protection, Associate Provost and Associate and Professor, Clinical Medical Humanities, University of Rochester Medical Center, Rochester, NY

David C. Clark, Ph.D.
Stanley G. Harris Family Professor of Psychiatry, Director and AVP, Research Compliance, Rush-Presbyterian-St. Luke's Medical Center, Chicago, IL

Jeffrey M. Cohen, Ph.D.
Associate Dean for Research, Weill Medical College of Cornell University, Former Associate Director of Education, Office for Human Research Protections, Department of Health and Human Services, New York, NY

Richard Coico, MD
Department of Microbiology & Immunology, CUNY Medical School, City College of New York, New York, NY

Deborah Collyar
President, Patient Advocates In Research, Blackhawk, CA

Kenneth Dretchen, MD
Professor and Chairman, Department of Pharmacology and Director, Office of Regulatory Affairs, Georgetown University Medical Center, Washington DC

Marianne M. Elliott, M.S., C.I.P.
Director Office of Research Administration, Naval Medical Research Center, Silver Spring, MD

Anthony L. Farino
Partner, PricewaterhouseCoopers, Chicago, IL

Paul W. Goebel, Jr.
Vice President, Chesapeake Research Review, Inc., Former Associate Director for Human Subject Protection, Office of Medical Policy, Center for Drug Evaluation and Research, Food and Drug Administration, Bethesda, MD

Alan S. Goldberg, JD, LLM
Partner, Goulston & Storrs, Adjunct Professor, University of Maryland School of Law, Moderator, AHLA HIT Listserve, Washington, DC

Kate-Louise Gottfried, JD, MSPH
Director of Research Integrity, Research Administration, Tufts-New England Medical Center, Boston, MA

Dale E. Hammerschmidt, MD, FACP
Associate Professor of Medicine, University of Minnesota, Editor in Chief, Journal of Laboratory and Clinical Medicine, Minneapolis, MN

Paul S. Hammond, MD, Dphil
Director, Western Regional Office, Office of Research Oversight, Department of Veterans Affairs, Moreno Valley, CA

John Isidor, JD
Chief Executive Officer, Schulman Associates Institutional Review Board, Cincinnati, OH

Nancy M. P. King, JD
Professor of Social Medicine, School of Medicine, University of North Carolina, Chapel Hill, NC

Richard P. Kusserow
President, Strategic Management Systems, Inc., Former Inspector General, Department of Health & Human Services, Washington, DC

Susan Martin, MS, CSHM
Director, Office of Environmental Health and Safety, Georgetown University, Washington, DC

Susan McAndrew, Esq.
Senior Advisor for HIPAA Privacy Policy, Office for Civil Rights, Department of Health and Human Services, Washington, DC

E. Haavi Morreim, Ph.D.
Professor, Department of Human Values and Ethics, College of Medicine, University of Tennessee, Memphis, TN

Jay Moskowitz, Ph.D.
Associate Vice President for Health Sciences Research and Vice Dean for Research and Graduate Studies, College of Medicine, The Pennsylvania State University, Hershey, PA

Daniel K. Nelson, MD
Director, Office of Human Research Ethics, Associate Professor of Social Medicine and Pediatrics, University of North Carolina-Chapel Hill, Chapel Hill, NC

Steven Peckman
Associate Director-Human Subjects Research, Office for Protection of Research Subjects, University of California, Los Angeles, Los Angeles, CA

Carol Pratt, JD, Ph.D.
Associate, Davis Wright Tremaine, Portland, OR

Ernest Prentice, Ph.D.
Associate Vice Chancellor for Academic Affairs, University of Nebraska Medical Center, Chair, DHHS Advisory Committee on Human Research Protection, Omaha, NE

Susan L. Rose, Ph.D.
Human Subjects Program Manager, Office of Biological and Environmental Research, Department of Energy, Washington DC

Janet Rehnquist, Esq.
Partner, Venable LLP, Former Inspector General, Department of Health & Human Services, Washington, DC

Ned Rubin, RN, CS-P
Friends Research Institute, Baltimore, MD

Partner, Sidley Austin Brown and Wood, Washigton, DC

Brenton L. Saunders, JD, MBA
Senior Vice President, Global Compliance and Business Practices, Schering-Plough Corporation, Past President, Health Care Compliance Association, Founder and Chair-elect, International Association of Privacy Officers, Kenilworth, NJ

Patricia M. Scannell, BA, CIP
Director, Human Studies Committee, Washington University Medical Center of St. Louis, St. Louis, MO

Bernard A. Schwetz, DVM, Ph.D.
Director, Office for Human Research Protections, Department of Health and Human Services, Rockville, MD

Ada Sue Selwitz, MA
Director, Office of Research Integrity, University of Kentucky, Lexington, KY

Joseph R. Sherwin, Ph.D.
Director, Office of Regulatory Affairs, University of Pennsylvania, Philadelphia, PA

Harry Shulman, Esq.
Partner, Davis Wright Tremaine LLP, San Francisco, CA

Jeremy Sugarman, MD, MPH, MA
Director, Center for the Study of Medical Ethics and Humanities, Duke University Medical Center, Durham, NC

Michael P. Swiatocha
Vice President, SPRI Compliance Officer, Schering-Plough Corporation, Kenilworth, NJ

Lynn Willis
Western Regional Office, Office of Research Oversight, Department of Veterans Affairs, Moreno Valley, CA

Franklin Zieve, MD, PhD
Associate Chief of Staff for Research, McGuire VA Medical Center, Richmond, VA

Sheila Cohen Zimmet, RN, JD
Director of Research Assurance and Compliance, Georgetown University Medical Center, Washington, DC



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