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  Day Two

 

Agenda: Day 1
Thursday, March 6, 2003


8:00 a.m. Welcome and Introduction

Robert M. "Skip" Nelson, MD, Ph.D.
Associate Professor of Anesthesia and Pediatrics
Chair, Committee for the Protection of Human Subjects
The Children's Hospital of Philadelphia
Philadelphia, PA
(Co-chair)

Michele Russell-Einhorn, Esq.
Director, Clinical Research Consulting Team
PricewaterhouseCoopers LLP
Former Director of Regulatory Affairs Office for Human Research Protection
Department of Health Human Services
Washington, DC
(Co-chair)
Presentation Material (Acrobat)
Presentation Material (Powerpoint)


8:15 a.m.

Medical Research in Times of Bioterrorism

Michael Carome, MD
Associate Director for Regulatory Affairs
Office for Human Research Protections, DHHS
Rockville, MD
Presentation Material (Acrobat)
Presentation Material (Powerpoint)

Jack Killen, MD, NIAID
Assistant Director for Biodefense Research
National Institute of Allergy and Infectious Diseases
Bethesda, MD
Presentation Material (Acrobat)
Presentation Material (Powerpoint)

Kenneth Shine, MD
Director, RAND Center for Domestic and International Health Security
Former President, Institute of Medicine
Washington, DC
Presentation Material (Acrobat)
Presentation Material (Powerpoint)

Dixie R. Snider, Jr., MD
Associate Director of Science, Center for Disease Control
Atlanta, GA
Presentation Material (Acrobat)
Presentation Material (Powerpoint)

Michele Russell-Einhorn, Esq.
Director, Clinical Research Consulting Team
PricewaterhouseCoopers LLP
Former Director of Regulatory Affairs Office for Human Research Protection
Department of Health Human Services
Washington, DC
(Moderator)

9:30 a.m.

The Dryvax Vaccine Case: A Discussion of the OHRP 407

Dale E. Hammerschmidt, MD, FACP
Director of Education, Human Subjects Protection
University of Minnesota
Editor in Chief, Journal of Laboratory and Clinical Medicine
Minneapolis, MN

Mary Faith Marshall, Ph.D.
Former Chairperson
National Human Research Protections Advisory Committee, and Director
Program in Bioethics, University of Kansas Medical Center
Kansas City, KS

Robert M. "Skip" Nelson, MD, Ph.D.
Associate Professor of Anesthesia and Pediatrics
Chair, Committee for the Protection of Human Subjects
The Children's Hospital of Philadelphia
Philadelphia, PA

Ernest Prentice, Ph.D.
Associate Vice Chancellor for Academic Affairs
University of Nebraska Medical Center
Omaha, NE

Thomas Puglisi, Ph.D.
Clinical Research Consulting Team, PricewaterhouseCoopers
Former Director of Human Subject Protections
Office for Human Research Protections, DHHS
Washington, DC
(Moderator)

10:30 a.m.

Break

11:00 a.m.

CONCURRENT SESSIONS I



1.01 Fraud and Abuse in Research: A Pharmaceutical Sponsor Perspective

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



1.02 Adverse Event Reporting

Dale E. Hammerschmidt, MD, FACP
Director of Education, Human Subjects Protection
University of Minnesota
Editor in Chief, Journal of Laboratory and Clinical Medicine
Minneapolis, MN
Presentation Material (Acrobat)
Presentation Material (Powerpoint)



1.03 IRBs in the Community Hospital Setting with Particular Attention to HIPAA Compliance, State-Specific Consent Law, the Central IRB Project, Tissue Banking Initiatives, and Other Hot Topics

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



1.04 NCI Multi-site Trials and the Central IRB Project

Jacquelyn L. Goldberg, J.D.
Administrator, Central IRB Initiative
National Cancer Institute, NIH
Bethesda, MD
Presentation Material (Acrobat)
Presentation Material (Powerpoint)



1.05 Social and Behavioral Research

Ivor Pritchard, Ph.D.
Senior Research Analyst
Institute of Education Sciences
U.S. Department of Education
Washington, DC
Presentation Material (Acrobat)
Presentation Material (Powerpoint)

Noon

Luncheon and Presentations

Robert M. "Skip" Nelson, MD, Ph.D.
Associate Professor of Anesthesia and Pediatrics
Chair, Committee for the Protection of Human Subjects
The Children's Hospital of Philadelphia
Philadelphia, PA
(Co-chair)

12:30 p.m.

Government Up-Date on Medical Research Funding and Regulation

Michael Carome, MD
Associate Director for Regulatory Affairs
Office for Human Research Protections, DHHS
Rockville, MD
Presentation Material (Acrobat)
Presentation Material (Powerpoint)

John Mather, MD
Chief Officer
Office of Research Compliance and Assurance Department of Veterans Affairs
Washington, DC

Allan C. Shipp, MHA
Director of Outreach, Office of Biotechnology Activities
Office of Biotechnology Activities
National Institutes of Health
Bethesda, MD

Mary McCabe
Director, Office of Education and Special Initiatives
National Cancer Institute
Bethesda, MD
Presentation Material (Acrobat)
Presentation Material (Powerpoint)

Mary Faith Marshall, Ph.D.
Former Chairperson, National Human Research Protections Advisory Committee
Director, Program in Bioethics
University of Kansas Medical Center
Kansas City, KS
(Moderator)

1:15 p.m.

Update on DHHS Advisory Committee on Human Research Protection

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

1:45 p.m.

Transition Break

2:00 p.m.

CONCURRENT SESSIONS II



2.01 Conducting a Compliance Assessment and Building Internal Controls in a Pharmaceutical R & D Operation

Allen G. Ditch
Director, GCP/GLP
Sales & Marketing Corporate Quality
Bristol-Myers Squibb Company
Syracuse, NY
Presentation Material (Acrobat)
Presentation Material (Powerpoint)

Michael Swiatocha
Director, PricewaterhouseCoopers
Florham Park, NJ
Presentation Material (Acrobat)
Presentation Material (Powerpoint)



2.02 What FDA Looks for When Inspecting IRBs and Sponsors

Marian S. Serge, RN
Nurse Consultant, Division of Bioresearch Monitoring
Office of Compliance
Center for Devices and Radiological Heath
Food and Drug Administration
Rockville, MD
Presentation Material (Acrobat)
Presentation Material (Powerpoint)



2.03 R & D Privacy Issues for a Pharmaceutical Manufacturer

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



2.04 Research Involving Children

Robert M. "Skip" Nelson, MD, Ph.D.
Associate Professor of Anesthesia and Pediatrics
Chair, Committee for the Protection of Human Subjects
The Children's Hospital of Philadelphia
Philadelphia, PA
Presentation Material (Acrobat)
Presentation Material (Powerpoint)
Handout Material (Acrobat)



2.05 Education and Training in Human Subject Protections

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, DHHS
New York, NY
Presentation Material (Acrobat)
Presentation Material (Powerpoint)

3:00 p.m.

Transition Break

3:15 p.m.

CONCURRENT SESSIONS III



3.01 NIH Enhancement Grants

Belinda Seto, Ph.D.
Acting Deputy Director, Office of Extramural Research
National Institutes of Health
Bethesda, MD
Presentation Material (Acrobat)
Presentation Material (Microsoft Word)



3.02 Independent IRBs

Gary L. Yingling, Esq.
Partner, Kilpatrick & Lockhart
Former President, Food and Drug Law Institute
Washington, DC
Presentation Material (Acrobat)
Presentation Material (Microsoft Word)



3.03 The Impact of HIPAA on Research Operations

Thomas Puglisi, Ph.D.
Clinical Research Consulting Team, PricewaterhouseCoopers
Former Director of Human Subject Protections
Office for Human Research Protections, DHHS
Washington, DC
Presentation Material (Acrobat)
Presentation Material (Microsoft Word)

Michele Russell-Einhorn, Esq.
Director, Clinical Research Consulting Team
PricewaterhouseCoopers LLP
Former Director of Regulatory Affairs Office for Human Research Protection
Department of Health Human Services
Washington, DC
Presentation Material (Acrobat)
Presentation Material (Microsoft Word)




3.04 IRB and QI - An Uneasy Marriage

Janet Brown, JD, MSW
Assistant Attorney General
State of Maryland Department of Health and Mental Hygiene
Baltimore, MD

Robert Schwartz, MD
Medical Director
Friends Research Institute, Inc.
Baltimore, MD

Adil Shamoo, Ph.D.
Professor, Department of Biochemistry and Molecular Biology
University of Maryland School of Medicine
Baltimore, MD

Ned Rubin, MS,RN,APRN
Director of Quality Improvement
Friends Research Institute, Inc.
Jacksonville, FL
(Moderator)



3.05 Investigating Allegations of Scientific Misconduct and the False Claims Act

Edwin Rauzi, Esq.
Partner, Davis Wright Tremaine
Seattle, WA
Presentation Material (Acrobat)

4:15 p.m.

Transition Break

4:30 p.m.

The Duke Center for BioEthics Program

Jeremy Sugarman, MD, MPH, MA
Director, Center for the Study of Medical Ethics and Humanities
Duke University Medical Center
Durham, NC
Presentation Material (Acrobat)
Presentation Material (Powerpoint)

5:15 p.m.

A Panel Discussion: The Medical Research Enterprise from a National and International Perspective

Oppel Greeff, MD
President, Global Product Development
Quintiles Transnational Corporation
Research Triangle Park, NC

John Kelly, MD, Ph.D.
Senior Vice President, Science and Regulatory Affairs, PhRMA
Washington, DC

Mary McCabe
Director, Office of Education and Special Initiatives
National Cancer Institute
Bethesda, MD
Presentation Material (Acrobat)
Presentation Material (Powerpoint)

Roger E. Meyer, MD
Senior Consultant on Clinical Research
Association of American Medical Colleges
Washington, DC

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

6:30 p.m.

Adjournment and Networking Reception

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