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Agenda: Day 2
Thursday, April 22, 2004



8:00 a.m.

Welcome and Introduction to Morning Plenary Session

Thomas Puglisi, Ph.D.
Global Pharmaceutical & Health Sciences Group
PricewaterhouseCoopers
Former Director of Human Subject Protections
Office for Human Subjects Research Protections
Department of Health and Human Services
Washington DC
(Conference Co chair)

8:15 a.m.

Anatomy of a Lawsuit: Practical Realities of Clinical Trials Litigation

E. Haavi Morreim, Ph.D.
Professor, Department of Human Values and Ethics
College of Medicine, University of Tennessee
Memphis, TN
Presentation Material (Acrobat)
Presentation Material (Powerpoint)

8:45 a.m.

Clinical Trial Guidance and Oversight: Lesson From Gene Transfer Research

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

Allan C. Shipp
Director of Outreach
NIH Office of Biotechnology Activities
Bethesda, MD
Presentation Material (Acrobat)
Presentation Material (Powerpoint)

Nancy M. P. King, JD
Professor of Social Medicine, School of Medicine
University of North Carolina
Chapel Hill, NC
(Moderator)
Presentation Material (Acrobat)
Presentation Material (Powerpoint)
Handout Material (Acrobat)


9:45 a.m.

The Role of Patient Advocates in Medical Research

Deborah Collyar
President, Patient Advocates In Research
Blackhawk, CA
Presentation Material (Acrobat)
Presentation Material (Powerpoint)

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

E. Haavi Morreim, Ph.D.
Professor, Department of Human Values and Ethics
College of Medicine, University of Tennessee
Memphis, TN
(Moderator)
Presentation Material (Acrobat)
Presentation Material (Powerpoint)

10:45 a.m.

Break

11:15 a.m.

CONCURRENT SESSIONS I



1.01 FDA Compliance Actions Against IRBs and Clinical Investigators

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
Presentation Material (Acrobat)
Presentation Material (Powerpoint)



1.02 Using Technology to Strengthen Human Subject Protections

Patricia M. Scannell, BA, CIP
Director, Human Studies Committee
Washington University Medical Center of St. Louis
St. Louis, MO
Presentation Material (Acrobat)
Presentation Material (Powerpoint)



1.03 Social and Behavioral Research Update

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
Presentation Material (Acrobat)
Presentation Material (Powerpoint)



1.04 Should We or Shouldn't We: The Decision to Create a Scientific Review Committee

Kate-Louise Gottfried, JD, MSPH
Director of Research Integrity
Research Administration
Tufts-New England Medical Center
Boston, MA
Presentation Material (Acrobat)
Presentation Material (Powerpoint)



1.05 Issues in Pharmaceutical Manufacturers Funding of Medical Research

Suzanne K. Sterling, Esq.
Partner, Ruden McClosky
and Former Counsel, CIBA-GEIGY
Miami, FL

12:15 p.m.

Networking Luncheon in the Exhibit Hall

1:15 p.m.

CONCURRENT SESSIONS II



2.01 IRB Conflicts of Interest

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



2.02 HIPAA Compliance in Medical Research

Amanda J. Hammond, JD
Associate, Global Pharmaceuticals and Health Sciences Group
PricewaterhouseCoopers
Washington, DC
Presentation Material (Acrobat)
Presentation Material (Powerpoint)

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

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



2.03 Recruitment and Nurturing of Clinical Investigators

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
Presentation Material (Acrobat)
Presentation Material (Powerpoint)



2.04 Advanced Medical Research Disclosure and Consent Issues

Harry Shulman, Esq.
Partner, Davis Wright Tremaine LLP
San Francisco, CA
Presentation Material (Acrobat)
Presentation Material (Powerpoint)



2.05 Compliance Issues for Medical Research in Department of Veterans Affairs Health Care Systems

Joan P. Porter, DPA, MPH
Associate Director
Office of Research Oversight
Washington, DC
Presentation Material (Acrobat)
Presentation Material (Powerpoint)

2:15 p.m.

Transition Break

2:30 p.m.

CONCURRENT SESSIONS III



3.01 Quality Assurance Programs

Ned Rubin, RN, CS-P
Friends Research Institute
Baltimore, MD
Presentation Material (Acrobat)
Presentation Material (Powerpoint)

Ada Sue Selwitz, MA
Director, Office of Research Integrity
University of Kentucky
Lexington, KY
Presentation Material (Acrobat)
Presentation Material (Powerpoint)

Joseph R. Sherwin, Ph.D.
Director, Office of Regulatory Affairs
University of Pennsylvania
Philadelphia, PA
Presentation Material (Acrobat)
Presentation Material (Powerpoint)



3.02 Compliance Issues for Medical Research at Healthcare Systems

Jerry Castellano, PharmD, CIP
Corporate Director, Institutional Review Board
Christiana Care Health System
Wilmington, DE
Presentation Material (Acrobat)
Presentation Material (Powerpoint)



3.03 Investigator Education: Training for Accountability in Human Research Protection Programs

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
Presentation Material (Acrobat)
Presentation Material (Powerpoint)

Marianne M. Elliott, M.S., C.I.P
Director, Office of Research Administration
Naval Medical Research Center
Silver Spring, MD
Presentation Material (Acrobat)
Presentation Material (Powerpoint)

Lynn Willis
Western Regional Office, Office of Research Oversight
Department of Veterans Affairs
Moreno Valley, CA
Presentation Material (Acrobat)
Presentation Material (Powerpoint)



3.04 Clinical Trials of Off-label Drug Uses - A Regulatory Minefield

Carol Pratt, JD, Ph.D.
Associate, Davis Wright Tremaine
Portland, OR
Presentation Material (Acrobat)
Presentation Material (Powerpoint)



3.05 Financial Disclosures and Conflicts of Interest in Clinical Research

Ron H. Clark, JD, MA, Ph.D.
Partner, Arent Fox Kintner Plotkin & Kahn, PLLC
Washington, DC
Presentation Material (Acrobat)
Presentation Material (Powerpoint)

Richard S. Liner, Esq.
Partner, Arent Fox PLLC
Washington, DC

3:30 p.m.

Transition Break

3:45 p.m.

Are IRBs Efficient, Effective or Redundant?

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
Presentation Material (Acrobat)
Presentation Material (Powerpoint)

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
Presentation Material (Acrobat)
Presentation Material (Powerpoint)

Alison Fanelli
Project Manager, IRBNet
Committee for the Protection of Human Subjects
Dartmouth College
Hanover, NH
Presentation Material (Acrobat)
Presentation Material (Powerpoint)

Dale E. Hammerschmidt, MD, FACP
Associate Professor of Medicine
University of Minnesota
Editor in Chief, Journal of Laboratory and Clinical Medicine
Minneapolis, MN
(Moderator)
Presentation Material (Acrobat)

4:45 p.m.

How Would YOU Revise the Human Subject Research Regulation?

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

Laura Odwazny, Esq.
Senior Attorney
Office of the General Counsel
Public Health Division
Department of Health and Human Services
Rockville, MD
Presentation Material (Acrobat)
Presentation Material (Powerpoint)

Steven Peckman
Associate Diector-Human Subjects Research
Office of Protection of Research Subjects
University of California, Los Angeles
Los Angeles, CA
Presentation Material (Acrobat)
Presentation Material (Powerpoint)

Thomas Puglisi, Ph.D.
Global Pharmaceutical & Health Sciences Group
PricewaterhouseCoopers
Former Director of Human Subject Protections
Office for Human Subjects Research Protections
Department of Health and Human Services
Washington DC
(Moderator)
Presentation Material (Acrobat)
Presentation Material (Powerpoint)

5:45 p.m.

Adjournment

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