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  Pre-Conference

  Day One

  Day Two

 

Agenda: Day 2
Friday, March 7, 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)

8:15 a.m.

Compliance Issues in Medical Research

Valli Baldassano
Senior Director Global Compliance
Associate General Counsel, Pharmacia
Peapack, NJ

Paul Kalb, MD, JD
Partner, Sidley Austin Brown & Wood, LLP
Washington, DC

Steve Peckman
Associate Director, Human Subjects Research
University of California, Los Angeles
Los Angeles, CA

James Sheehan, Esq.
Chief of the Civil Division
Assistant U.S. Attorney
U.S. Attorney's Office for the Eastern District of Pennsylvania
Philadelphia, PA

Seth Whitelaw
Compliance Officer, Global R&D
GlaxoSmithKline
Philadelphia, PA

Brent Saunders, JD, MBA
Partner, PricewaterhouseCoopers, LLP
Founder and First VP
International Association of Privacy Professionals
Past President, Health Care Compliance Association
Florham Park, NJ
(Moderator)

9:30 a.m.

Tissue Banking and Repositories: The National Marrow Donor Program Experience

Marianna Bledsoe, MA
Program Director, Resources Development Branch
National Cancer Institute
Rockville, MD
Presentation Material (Acrobat)
Presentation Material (Powerpoint)
Handout Material (Acrobat)
Handout Material (Microsoft Word)

Dennis Confer, MD
Chief Medical Officer
National Marrow Donor Program
Minneapolis, MN
Presentation Material (Acrobat)
Presentation Material (Powerpoint)

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 (Powerpoint)

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
(Moderator)

10:45 a.m.

Transition Break

11:00 a.m.

CONCURRENT SESSIONS IV



4.01 Part 11 Compliance

Pat Roche
Senior Manager
PricewaterhouseCoopers
Florham Park, NJ
Presentation Material (Acrobat)
Presentation Material (Powerpoint)



4.02 National Surgical Adjuvant Breast and Bowel Project: Current Issues

Joyce Mull, MPM
Director, NSABP Foundation, Inc.
National Surgical Adjuvant Breast and Bowel Project
Pittsburgh, PA
Presentation Material (Acrobat)
Presentation Material (Powerpoint)



4.03 AAHRPP Accreditation of Human Research Protection Programs

Jeffrey A. Cooper, MD
Deputy Director
Association for Accreditation of Human Research Protection Programs
Washington, DC



4.04 International Issues in the Bioethics of Research

James Lavery, Ph.D.
Fogarty International Center
Bethesda, MD
Presentation Material (Acrobat)
Presentation Material (Powerpoint)

Barbara Sina, Ph.D.
Fogarty International Center
Bethesda, MD



4.05 Ethical Conundrum in Workplace Research and Screening

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

Noon

Luncheon and Presentations

12:30 p.m.

Litigation Involving Human Subjects in Research

Alan Milstein, Esq.
Partner
Sherman, Silverstein, Kohl, Rose & Podolsky
Pennsauken, NJ

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

Kendra Dimond, Esq.
Partner, Epstein Becker & Green
Washington, DC
(Moderator)

1:15 p.m.

The FDA's Regulation of Medical Research

Janet Woodcock, MD
Director, Center for Drug Evaluation and Research
Food and Drug Administration
Rockville, MD

2:00 p.m.

Implications for Medical Research of the Human Genome Project

Christopher Austin, MD
Senior Advisor to the Director for Translational Research
National Human Genome Research Institute
National Institutes of Health
Washington, DC
Presentation Material (Acrobat)
Presentation Material (Powerpoint)

2:45 p.m.

Transition Break

3:00 p.m.

CONCURRENT SESSIONS V



5.01 Data Monitoring Committees: A Regulator's Perspective

Mary Foulkes, Ph.D
Deputy Director, Office of Biostatistics and Epidemiology
Center for Biologics, Evaluation and Research
Food and Drug Administration
Rockville, MD
Presentation Material (Acrobat)
Presentation Material (Powerpoint)



5.02 Compliance Programs in AAMCs

Kenneth Dretchen, MD
Professor and Chairman
Department of Pharmacology
Director, Office of Regulatory Affairs
Georgetown University Medical Center
Washington, DC
Presentation Material (Acrobat)
Presentation Material (Powerpoint)

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



5.03 Conflict of Interest Issues with Investigators

Diane Dean
Director, Division of Grants Compliance & Oversight
Office of Policy for Extramural Research Administration
National Institutes of Health
Bethesda, MD

Holli Beckerman Jaffe, J.D.
Ethics Counsel
National Institutes of Health
Bethesda, MD

Robin Fritsch, J.D.
Alternate Designated Agency Ethics Official
National Science Foundation
Arlington, VA

Karen Santoro, Esq.
Deputy Ethics Counselor, National Institute for Allergies and Infectious Diseases
National Institutes of Health
Bethesda, MD



5.04 Inspections Update

Paul W. Goebel, Jr., CIP
Vice President, Chesapeake Research Review, Inc.
Former Associate Director for Human Subject Protection
Office of Medical Policy
Center for Drug Evaluation and Research, FDA
Columbia, MD
Presentation Material (Acrobat)
Presentation Material (Powerpoint)

4:00 p.m.

Ask the Experts: A Roundtable Q and A Session Regarding Medical Research Regulation and Compliance

Valli Baldassano
Senior Director Global Compliance
Associate General Counsel, Pharmacia
Peapack, NJ

Dennis Confer, MD
Chief Medical Officer
National Marrow Donor Program
Minneapolis, MN

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

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

Steve Peckman
Associate Director, Human Subjects Research
University of California, Los Angeles
Los Angeles, CA

5:00 p.m.

Adjournment

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