Third Annual Medical Research Summit: Agenda: Day Two

  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

top of page