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  Pre-Conference

  Day One

  Day Two

 
Agenda: Day 1
Monday, March 19, 2001


8:00 a.m.

Welcome and Introduction

Odell Guyton, Esq.
Corporate Compliance Officer
University of Pennsylvania
Philadelphia, PA

Michele Russell-Einhorn
Director
Clinical Research Consulting Team
PricewaterhouseCoopers
Former Director of Regulatory Affairs for the Office for Human Research Protection
Department of Health Human Services
Washington, DC
Conference Co-chairs


8:15 a.m.

Human Subject Protections: The View from Congress

Annette Dula, EdD
Senior Research Associate Women's Studies
University of Colorado at Boulder
Seattle, WA


8:45 a.m.

Human Subject Protections: Food and Drug Administration Policies

David Le Pay, MD
Acting Senior Advisor for Clinical Science, Food and Drug Administration
Office of the Commissioner
Rockville, MD


9:30 a.m.

Office for Human Research Protections Initiatives

Greg Koski, MD
Director
Office for Human Research Protections
Department of Health and Human Services
Rockville, MD


10:15 a.m.

Break


10:45 a.m.

CONCURRENT SESSIONS 1




101. Enforcement & Response: Investigator Misconduct in Your Organization

Sheila Zimmet, JD
Georgetown University
Washington, DC

Kathleen McDermott
Blank Rome Comisky & McCauly
Baltimore, MD




102. IRB Operations: ABC's of Establishing an IRB

Stephanie J. Taylor
Manager
Research Compliance
Greenville Hospital System
Greenville, SC

Adam Kohn, Esq.
Shaw Pittman
Washington, DC
Presentation Material A
Presentation Material B




103. Reimbursement and Finance: Medicare Billing and Reimbursement Essentials for Research

Soo Bang, Senior Associate
Clinical Research Consulting Team
PricewaterhouseCoopers
Washington, DC

Jorge Lopez, Esq.
Akin Gump Strauss Hauer & Feld
Washington, DC
Presentation Material




104. Research Compliance A: The Effect of HIPAA on Research, Part I

Richard Marks, Esq.
Partner
Davis Wright Tremaine LLP
Washington, DC

Carol Pratt, JD, PhD
Davis Wright Tremaine
Portland, OR
Presentation Material




105. Research Compliance B: Fraud and Abuse, Stark and Business Issues in Contracting With Research Sites and Investigators

Ron Wisor, Esq.
Arent Fox Kintner Plotkin & Kahn
Washington, DC

Elizabeth A. Lewis, Esq.
Epstein Becker & Green
Washington, DC
Presentation Material A
Presentation Material B
Presentation Material C


11:45 a.m.

LUNCHEON AND PRESENTATIONS


12:15 p.m.

The Impact of Information Technology on Clinical Research

John Cline
CEO
ETRIALS
Morrisville, NC
Presentation Material


1:00 p.m.

Emerging Governmental Initiatives in Medical Research

Chris Pascal
Director
Office of Research Integrity
Department of Health & Human Services
Washington, DC

Melanie Lynn, PhD
Deputy Director
Human Subject Protections
Office for Human Research Protections
Rockville, MD

Belinda Seto, PhD
Director
Office of Reports & Analysis
Office of Extramural Research
National Institutes of Health
Bethesda, MD

Peter Harrington

Michele Russell-Einhorn
Director
Clinical Research Consulting Team
PricewaterhouseCoopers LLP
Washington, DC (Moderator)
Presentation Material A
Presentation Material B
Presentation Material C


2:15 p.m.

TRANSITION BREAK


2:30 p.m.

CONCURRENT SESSIONS 2




201. Enforcement and Response: Whistleblowers in Research: The Role of the False Claims Act

Christopher A. Myers, Esq.
Partner
Holland & Knight
Washington, DC

Edwin Rauzi, Esq.
Partner
Davis Wright Tremaine LLP
Seattle, WA
Presentation Material A
Presentation Material B
Presentation Material C
Presentation Material D




202. Financing Research Compliance Operations

David Hudson, PhD
Associate Vice President for Research & Public Service
University of Virginia
Charlottesville, VA

Anthony M. Boccanfuso, PhD
Manager
Clinical Research Consulting Team
PricewaterhouseCoopers LLP
Charlotte, NC




203. Enforcement & Response: Assuring Scientific Integrity

Kim Gunter, LLM, JD
Senior Associate
PricewaterhouseCoopers
Philadelphia, PA

Karen Santoro, JD
Deputy Ethics Council
NIAID
NIH
Bethesda, MD

Caroline Elmendorf
Department of Health & Human Services
Washington, DC
Presentation Material A
Presentation Material B




204. Research Compliance A: The Effect of HIPAA on Research, Part II

Richard Marks, Esq.
Partner
Davis Wright Tremaine LLP
Washington, DC

Carol Pratt, JD, PhD
Davis Wright Tremaine LLP
Portland, OR
Presentation Material




205. Research Compliance B: Old and New Issues in Recruiting Subjects for Clinical Trials

Karen McDonnell Suddath, Esq.
Pepper Hamilton LLP
Philadelphia, PA


3:30 p.m.

TRANSITION BREAK


3:45 p.m.

CONCURRENT SESSIONS 3




301. Enforcement & Response: Responding to Government Investigation

Harvey Yampolsky, Esq.
Partner
Arent Fox Kintner Plotkin & Kahn
Former Chief Counsel to the Inspector General
Department of Health & Human Services
Washington, DC




302. Maintaining Compliance in a Growing Research Environment

Leslie Platt, JD
Principal & Leader
Health Sciences Research Compliance Group
Ernst & Young LLP
McLean, VA




303. Reimbursement and Finance: Implementing the National Coverage Decision for Clinical Trials

Diane Lee, Esq.
Partner
Davis Wright Tremaine LLP
San Francisco, CA

Karen Dunlop, Esq.
Sidley & Austin
Chicago, IL




304. Research Compliance A: Special Issues in International Research

Shirley Hicks
National Institutes of Health
Bethesda, MD




305. Research Compliance B: Investigator and Institutional Conflicts of Interest

Guy Collier, Esq.
Shaw Pittman
Washington, DC

Susan K. Burgess, Esq.
CCO
MCV Physicians
Richmond, VA


4:45 p.m.

TRANSITION BREAK


5:00 p.m.

The Government's Role in Supporting Biomedical Research

Representative Susan Myrick
United States House of Representatives
Washingon, DC


6:00 p.m.

ADJOURNMENT


6:30 p.m.

NETWORKING RECEPTION

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