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 Day One

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 Day Three


Symposium Agenda: Day 1
Wednesday, Aug. 23, 2006

7:00 a.m.

Registration and Continental Breakfast

8:00 a.m.

Welcome and Introduction, Morning Plenary Session

George M. Burditt, Esq.
Of Counsel, Drug and Device Law Group, Bell Boyd and Lloyd
Former General Counsel, Food and Drug Law Institute
Former Illinois State Representative
Chicago, IL

Nancy Singer, Esq.
President, Compliance-Alliance, LLC
Former Special Counsel, AdvaMed
Founder, AdvaMed Medical Technology Learning Institute
Arlington, VA

8:15 a.m.

Conference Goals

Arthur Miller, Esq.
Bruce Bromley Professor of Law
Harvard Law School
Cambridge, MA

8:45 a.m.

Reflections of a Former FDA Commissioner

Jane Henney, MD
Senior Vice President and Provost for Health Affairs
University of Cincinnati Academic Health Center
Former Commissioner, FDA
Cincinnati, OH
No Presentation Provied

9:30 a.m.

A Regulator's Perspective: Risk-Based Approaches to Regulatory Oversight and Compliance

David Horowitz, Esq.
Deputy Associate Commissioner for Compliance Policy
Office of Regulatory Affairs, FDA
Washington, DC
Presentation Material (Acrobat)
Presentation Material (Powerpoint)

10:15 a.m.


10:45 a.m.

The Role of the FDA in Regulating Drug Marketing

Thomas Abrams, R.Ph., MBA
Director, Division of Drug Marketing
Advertising, and Communications, CDER, FDA
Washington, DC
Presentation Material (Acrobat)
Powerpoint too large to post

11:30 a.m.

The Role of the Department of Justice in Prosecuting Violations of FDA Regulations

James Sheehan, Esq.
Associate United States Attorney
U.S. Attorney's Office for the Eastern District of Pennsylvania
Philadelphia, PA
Presentation Material (Acrobat)
Presentation Material (Powerpoint)

12:15 p.m.

Luncheon at Harvard Faculty Club

1:45 p.m.

Overview of the FDA Regulatory Environment

Scott Gottlieb, MD
Deputy Commissioner for Medical and Scientific Affairs
Office of the Commissioner, FDA
Washington, DC

2:30 p.m.

The Intersection Between FDA and CMS Regulation

Peter Bach, MD, MAPP
Senior Advisor, Office of the Administrator
Centers for Medicare & Medicaid Services
Washington, DC
Presentation Material (Acrobat)
Presentation Material (Powerpoint)

3:15 p.m.

Perspectives on the Role of the FDA in Drug Safety

Eric Topol, MD
Professor, Department of Genetics
Case Western Reserve University
Cleveland, OH
Permission to post not granted

4:00 p.m.


4:30 p.m.

Perspectives on New Paradigms of Risk and Compliance in Pharmaceutical Development: Quality by Design, PAT and Design Space

David J. Cummings
Office of Pharmaceutical Science (OPS) Quality System Manager
Silver Spring, MD
Presentation Material (Acrobat)
Presentation Material (Powerpoint)

Brad Dawson
Director, Life Sciences Consulting
Sunnyvale, CA
Presentation Material (Acrobat)
Presentation Material (Powerpoint)

5:15 p.m.

Reflections on the Role of the FDA: Past, Present and Future

Philip Hilts
Former Science Reporter, The New York Times and The Washington Post
Lecturer, Department of Journalism, Boston University
Author, Protecting America's Health: The FDA, Business, and One Hundred Years of Regulation and RX for Survival: Why We Must Rise to the Global Health Challenge
Winner, 2004 Los Angeles Times Book Prize for Science and Technology and The New York Times Notable Book of the Year distinction

Brookline, MA
Adobe Acrobat too large to post
Presentation Material (Powerpoint)

6:00 p.m.

Adjournment and Networking Reception

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