Pre-Conference
Day One
Day Two
Day Three
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Agenda: Pre-Conference
Wednesday, August 24, 2005
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7:00 a.m. |
Registration Commences at Annenberg Hall, Harvard University
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8:30 a.m. |
Special Preconference Workshop: Best Practices for Getting Cooperation for Risk Management and Corporate Compliance
Using the ideas gained from the 1,024 responses to the Compliance-Alliance Survey on RA/QA Influence, workshop participants will be able to benchmark their practices for getting all departments to comply with regulatory requirements with those of other drug and device firms. General topics include:
- Getting the Support of Top Management
- Making Compliance Part of Everyone's Job
- Empowering Quality Officials
- Employing the Appropriate Skills
- Educating Other Departments
- Selling the Benefits of Compliance
- Using Internal Audits Effectively
- Communicating the Consequences of Noncompliance
John T. Bentivoglio, Esq.
Partner, King & Spalding
Former Special Counsel for Healthcare Fraud
Chief Privacy Officer, United States Department of Justice
Washington, DC
David L. Leo
President, Biomedical Resource Consultants
Chair, American Society for Quality
Biomedical Division
Wilbraham, MA
Nan Matthews
President, The Matthews Group
Littleton, CO
Steve Ojala, Ph.D.
Global Director, Eli Lilly
Indianapolis, IN
Pam Weagraff
Founder and Principal, Acelera Consulting
Former Vice President of Regulatory
Clinical and Quality, MediSpectra
North Reading, MA
Nancy Singer, Esq.
President, Compliance-Alliance
Former Special Counsel, AdvaMed
Founder, AdvaMed Medical Technology Learning Institute
Arlington, VA
(Co-chair)
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Noon |
Preconference Workshop Adjournment
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FDA Symposium Agenda: Day 1
Wednesday, August 24, 2005
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Afternoon Plenary Session
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1:00 p.m. |
Welcome and Introductions
Daniel E. Troy, Esq.
Partner, Sidley Austin Brown & Wood
Former Chief Counsel, Office of the General Counsel
Food and Drug Administration
Washington, DC
(Symposium Co-chair)
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1:15 p.m. |
What We Know and What We Came to Learn
Arthur Miller, Esq.
Bruce Bromley Professor of Law
Harvard Law School
Cambridge, MA
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1:45 p.m. |
An Overview of the FDA's Regulatory/Compliance Agenda
John M. Taylor, III
Former Associate Commissioner for Regulatory Affairs
Food and Drug Administration
Potomac, MD
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2:30 p.m. |
The Implications of Vioxx: An Overview of FDA Regulatory and Compliance Challenges Facing Pharmaceutical Compliance Professionals
Daniel E. Troy, Esq.
Partner, Sidley Austin Brown & Wood
Former Chief Counsel, Office of the General Counsel
Food and Drug Administration
Washington, DC
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3:15 p.m. |
Break
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3:45 p.m. |
Lessons Learned After Years of Watching the FDA React to Actual or Perceived Health Crises
and Political Pressures
Peter Barton Hutt, Esq.
Senior Counsel, Covington & Burling
Former Chief Counsel, Office of the General Counsel
Food and Drug Administration
Washington, DC
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4:30 p.m. |
Decreasing Cost by Integrating Compliance Into Your Core Business Processes
Matthew R. Weinberg
Chief Executive Officer
THE WEINBERG GROUP
Washington, DC
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5:15 p.m. |
Managing Your Product Pipeline in This New Era of FDA Scrutiny
William K. Sietsema, Ph.D.
Vice President, Clinical Affairs, Kendle
Cincinnati, OH
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6:00 p.m. |
Adjournment and Opening Reception
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