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  Pre-Conference

  Day One

  Day Two

 

Agenda: Day 2
Tuesday, March 26, 2002


8:00 a.m.

Welcome and Introduction to Day Two


8:15 a.m.

An Update - When Things Go Wrong in the Conduct of Clinical Research: Lessons Learned

Stephen F. Hanlon, Esq.
Member
Holland & Knight
Tallahassee, FL

Alan C. Milstein, Esq.
Partner
Sherman, Silverstein, Kohl, Rose & Podolsky
Pennsauken, NJ
Presentation Material (Acrobat)
Presentation Material (Powerpoint)


9:15 a.m.

The Future of Pharmaceutical Research and Development

J.D. Kleinke
President
Health Strategies Network
Author
Bleeding Edge: The Business of Health Care in the New Century and Oxymorons: The Myth of a U. S. Health Care System
Denver, CO
Presentation Material (Acrobat)
Presentation Material (Powerpoint)


10:15 a.m.

Responding to the Threat of Bioterrorism: A Status Report on Vaccine Research in the United States

Dixie E. Snider, Jr., M.D.
Associate Director of Science
Center for Disease Control and Prevention
Atlanta, GA
Presentation Material (Acrobat)
Presentation Material (Powerpoint)


11:15 a.m.

TRANSITION BREAK


11:30 a.m.

CONCURRENT SESSIONS IV




4.01 Academic Medical Centers and Pharmaceutical Companies: Improving Relationships in the Medical Research Context

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




4.02 Billing and Research: A Practical Approach Towards Compliance

Kim St. Amant, CPA
Senior Manager
National Clinical Research Consulting Team
Deloitte & Touche LLP
Boston, MA

Sandy Piersel
Senior Manager
National Clinical Research Consulting Team
Deloitte & Touche LLP
Philadelphia, PA
Presentation Material (Acrobat)
Presentation Material (Powerpoint)




4.03 Managing Institution-Investigator Relationships

Sandra A. Davis
Director
Risk and Compliance Services
Huntington Memorial Hospital
Pasadena, CA




4.04 Negotiating Clinical Trials Agreements

William A. Knowlton, Esq.
Partner,
Ropes & Gray
Boston, MA

Jeff Kahn, Esq.
Associate General Counsel
Children's Hospital of Philadelphia
Philadelphia, PA
Presentation Material (Acrobat)
Presentation Material (Powerpoint)




4.05 Overview of Financial and Administrative Commitments of Clinical Research

Timothy J. Fournier
Senior Manager
Higher Education and Healthcare Consulting
Arthur Andersen LLP
Chicago, IL
Presentation Material (Acrobat)
Presentation Material (Powerpoint)


12:30 p.m.

Luncheon and Presentations


1:00 p.m.

Adverse Event Reporting: Trials and Tribulations

Michael Carome, MD
Director, Compliance Oversight
Office for Human Research Protections
Department of Health and Human Services
Rockville, MD
Presentation Material (Acrobat)
Presentation Material (Powerpoint)

Joanne R. Less, Ph.D.
Director, IDE/HDE Programs
Center for Devices and Radiological Health
Food and Drug Administration
Rockville, MD
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


2:00 p.m.

Annual Roundtable on Medical Research Compliance, Legal Counsel, Ethics and Privacy

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

Thomas E. Merchant, Esq.
Vice President
R & D Legal Operations U.S.
GlaxoSmithKline
King of Prussia, PA

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

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

John E. Steiner, Jr., Esq.
Chief Compliance Officer
Cleveland Clinic Health System
Cleveland, OH

Jay H. Tureen, MD
Director
Research Education and Compliance Program
Clinical Professor of Pediatrics
University of California, San Francisco
San Francisco, CA

Paul E. Kalb, JD, MD
Partner
Sidley Austin Brown & Wood
Washington, DC
(Moderator)


3:15 p.m.

TRANSITION BREAK


3:30 p.m.

CONCURRENT SESSIONS V




5.01 Clinical Research from the Independent IRB's View

Paul W. Goebel, Jr.
Vice President
Chesapeake Research Review, Inc.
Columbia, MD

Matthew D. Whalen, Ph.D.
President
Chesapeake Research Review, Inc.
Columbia, MD
Presentation Material (Acrobat)
Presentation Material (Powerpoint)




5.02 Advanced Issues In Research Compliance

Edward B. Goldman, Esq.
Health System Attorney
Office of General Counsel
University of Michigan Health System
Ann Arbor, MI
Presentation Material (Acrobat)
Presentation Material (Powerpoint)
Presentation Material (Acrobat)
Presentation Material (Powerpoint)




5.03 Epidemiological Studies: to Research or not to Research, That is the Question?

Thomas Puglisi, Ph.D.
Clinical Research Consulting Team
PricewaterhouseCoopers LLP
Former Director
Human Subject Protections
Office for Human Subjects Research Protections
Department of Health and Human Services
Bethesda, MD
Presentation Material (Acrobat)
Presentation Material (Powerpoint)




5.04 Benchmarking Clinical Research Compliance Efforts: Identifying and Avoiding Key Areas of Risk

H.Guy Collier
Partner
Health Law Department
ShawPittman LLP
Washington, DC
Presentation Material (Acrobat)
Presentation Material (Powerpoint)


4:30 p.m.

Adjournment

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