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  Pre-Conference/
  Day One

  Day Two

  Day Three

 

Agenda: Pre-Conference
Wednesday, April 21, 2004


9:00 a.m. - 12:00 noon PRECONFERENCE SYMPOSIA
(concurrent sessions; choose one session only)


Preconference I


Basic Human Subject Protection Training

CANCELLED


Preconference II


A Workshop on FDA Enforcement, Fraud and Abuse, the OIG's Guidelines for Investigator Compensation, and Other Compliance Issues in the Research and Development Process

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

Jonathon Kellerman
Senior Manager, PricewaterhouseCoopers
Philadelphia, PA
Presentation Material (Acrobat)
Presentation Material (Powerpoint)

William Sarraille
Partner, Sidley Austin Brown and Wood
Washington, DC

Michael P. Swiatocha
Vice President, SPRI Compliance Officer
Schering-Plough Corporation
Kenilworth, NJ


Preconference III


Adverse Event Reporting and Unanticipated Problems Involving Risks to Subjects and Others

Dale E. Hammerschmidt, MD, FACP
Associate Professor of Medicine, University of Minnesota
Editor in Chief, Journal of Laboratory and Clinical Medicine
Minneapolis, MN

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


Preconference IV


HHRP and PHRP Human Subject Research Protection Program Accreditation

CANCELLED

-- End Preconference --

-- Begin Conference --

Agenda: Day 1
Wednesday, April 21, 2004



1:00 p.m.

Welcome and Introduction

Michele Russell-Einhorn, JD
Associate General Counsel
J. Craig Venter Science Foundation
Former Director of Regulatory Affairs
Office for Human Research Protection
Department of Health and Human Services
Rockville, MD
(Conference Co chair)

1:15 p.m.

The Role of Medical Research in Reducing Medical Errors and Enhancing Healthcare Quality Patient Safety

Helen Burstin
Director, Center for Primary Care, Prevention, and Clinical Partnerships
Agency for Healthcare Research and Quality
Rockville, MD

2:15 p.m.

Responding to a Shut Down of Clinical Research: Creating a Research Ethics Infrastructure

Jeremy Sugarman, MD, MPH, MA
Phoebe R. Berman Bioethics Institute
Johns Hopkins University
Baltimore, MD

3:15 p.m.

Break

3:30 p.m.

Genomic Research: The Impact on Clinical Research

Vanessa King, Ph.D.
Vice President, External Development & Collaborations
The Center for the Advancement of Genomics
Rockville, MD

4:15 p.m.

Investigating Fraud and Abuse Violations in Medical Research

Richard P. Kusserow, President
Strategic Management Systems, Inc.
Former Inspector General, Department of Health & Human Services
Washington, DC

Janet Rehnquist, Esq.
Partner, Venable LLP
Former Inspector General, Department of Health & Human Services
Washington, DC
Presentation Material (Acrobat)
Presentation Material (Powerpoint)

5:15 p.m.

Prosecuting Medical Research Violations

David Hoffman, Esq.
Assistant U.S. Attorney
Eastern District of Pennsylvania
Philadelphia, PA
Presentation Material (Acrobat)
Presentation Material (Powerpoint)

6:00 p.m.

Adjournment and Networking Reception

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