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  Pre-Conference/
  Day One

  Day Two

  Day Three

 

Agenda: Day 3
Friday, April 23, 2004


8:00 a.m. 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.

Government in Research: Navigating Conflicts of Interest

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

8:45 a.m.

The Use of Hazardous Materials in Human Subjects Research

Susan Martin, MS, CSHM
Director, Office of Environmental Health and Safety
Georgetown University
Washington, DC
Presentation Material (Acrobat)
Presentation Material (Powerpoint)

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

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

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

9:45 a.m.

Bioterrorism: Changing Priorities in Medical Training and Research

Richard Coico, MD
Department of Microbiology & Immunology
CUNY Medical School
City College of New York
New York, NY
Presentation Material (Acrobat)
Presentation Material (Powerpoint)

Susan L. Rose, Ph.D.
Human Subjects Program Manager
Office of Biological and Environmental Research
Department of Energy
Washington DC
Handout Material (Acrobat)
Handout Material (Microsoft Word)

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
(Moderator)
Presentation Material (Acrobat)

10:45 a.m.

Break

11:15 a.m.

MEDICAL RESEARCH KNOWLEDGE EXCHANGE AND BEST PRACTICES SESSIONS
The Following Special Sessions are Facilitated Discussions; Please Come Prepared to Participate



4.01 How to Structure Your Research Compliance Program - Reporting, Scope, Resources and Approach

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



4.02 Research Compliance Auditing

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
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)



4.03 Research Compliance Training

Dawn Antonis
Associate Director for Global Compliance Training
Schering-Plough Corporation
Kenilworth, NJ
Presentation Material (Acrobat)
Presentation Material (Powerpoint)



4.04 Research Privacy Programs

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



4.05 Managing CROs and SMOs

Michael P. Swiatocha
Vice President, SPRI Compliance Officer
Schering-Plough Corporation
Kenilworth, NJ
Presentation Material (Acrobat)
Presentation Material (Powerpoint)

12:15 p.m.

Luncheon and Presentations

12:45 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
Presentation Material (Acrobat)
Presentation Material (Powerpoint)

1:30 p.m.

Emerging Issues and the Role of the Office for Human Research Protections

Bernard A. Schwetz, DVM, Ph.D.
Director, Office for Human Research Protections
Department of Health and Human Services
Rockville, MD
Presentation Material (Acrobat)
Presentation Material (Powerpoint)

2:00 p.m.

Government Medical Research Roundtable

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

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

Samuel N. Merrill, Jr., Ph.D.
Scientist-Investigator
Division of Investigative Oversight
Office of Research Integrity
Department of Health and Human Services
Washington, DC
Presentation Material (Acrobat)
Presentation Material (Powerpoint)

Paula Waterman, MS, CIP
Office of Research Oversight
Veterans Health Administration
Washington, DC
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)

3:00 p.m.

Adjournment

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