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The Third Annual FDA Regulatory and Compliance Symposium

Managing Risks - From Pipeline to Patient

August 21 - 24, 2007

Classes Held:
Harvard University's Annenberg Hall
Lowell Hall, Science Center
and the Harvard Faculty Club
Symposium Hotel:
The Charles Hotel, Cambridge, MA

FDA SYMPOSIUM MULTIMEDIA
Watch video of the 2007 FDA Symposium on the go. The FDA Symposium offers Podcasting of all general sessions on a 30gb Video iPOD™, a CD-ROM, or a Flash Drive. Concurrent breakout session audio and all related presentation materials are also included on each multimedia format.

Click here to order!

KEYNOTE SPEAKERS
Jerry Avorn, MD
Professor of Medicine, Harvard Medical School, Chief, Division of Pharmacoepidemiology and Pharmacoeconomics, Brigham and Women's Hospital, Author, Powerful Medicines and The Benefits, Risks, and Costs of Prescription Drugs, Boston, MA
Lester Crawford, DVM, PhD
Senior Counsel, Policy Directions, Inc., Former Commissioner, FDA, Washington, DC
Scott Gottlieb, MD
Resident Fellow, American Enterprise Institute, Former Commissioner for Medical and Scientific Affairs, FDA, Washington, DC
Sonali Gunawardhana, JD
Regulatory Counsel, Center for Devices and Radiological Health, FDA, Rockville, MD
Joseph Mahady
President, Global Business, Wyeth Pharmaceuticals, Collegeville, PA
Michelle M. Mello, JD, PhD
C. Boyden Gray Associate Professor of Health Policy and Law, Department of Health Policy and Management, Harvard School of Public Health, Boston, MA
Daniel Meron, Esq.
General Counsel, Department of Health and Human Services, Former Principal Deputy Assistant Attorney General, Civil Division, United States Department of Justice, Washington, DC
Arthur Miller, Esq.
Bruce Bromley Professor of Law, Harvard Law School, Cambridge, MA
Wayne Pines
President, FDA Alliance, President, Regulatory Services and Healthcare, APCO Worldwide, Former Associate Commissioner for Public Affairs, FDA, Washington, DC

Lucy Rose, MBA
President, Lucy Rose and Associates, LLC; Former Director of the Office of Training and Communications and DDMAC, CDER, FDA
David Rothman, PhD
Bernard Schoenberg Professor of Social Medicine, Director of the Center for the Study of Society and Medicine, Columbia College of Physicians and Surgeons, Professor of History, Columbia University, New York, NY
James G. Sheehan, Esq.
New York State Medicaid, Inspector General, Former Associate United States Attorney, U.S. Attorney's Office for the Eastern District of Pennsylvania, Albany, NY
Tom Stossel, MD
Department of Medicine, Harvard Medical School, Co-Director, Division of Hematology, Brigham and Women's Hospital, Boston, MA
Daniel Troy, Esq.
Partner, Sidley Austin Brown & Wood, Former Chief Counsel, Office of the General Counsel, FDA, Washington, DC
Marc Wilenzick, Esq.
Assistant General Counsel, Pfizer, New York, NY
Helen Winkle
Director, Office of Pharmaceutical Science, Center for Drug Evaluation and Research, FDA
Susan Wood, PhD
Research Professor, School of Public Health and Health Services, George Washington University, Former Assistant Commissioner for Women's Health, and Director of the Office of Women's Health, FDA, Washington, DC

FEATURED FACULTY
David Balto, Esq.
Private Practice; Former Policy Director of the Bureau of Competition of the Federal Trade Commission, Washington, DC

Charles Bennett, MD, PhD
Professor of Medicine, Northwestern Medical School, Chicago, IL

Richard J. Berman, Esq.
Partner, Arent Fox LLP, Washington, DC

Robert Campbell, JD, MPH, PhD
Health Services Researcher, VISN 8 Patient Safety Center, Tampa, FL

Dave Ceryak, Esq.
Assistant General Counsel, Eli Lilly and Company, Indianapolis, IN

Cathryn Clary, MD, MBA
Vice President, External Medical Affairs, Pfizer, New York, NY

Fran Cunningham, PharmD
Director, VHA Medication Safety Center, Chicago, IL

Kelly Freeman, PhD, MSc
Director, US Affiliate, Compliance and Ethics, Eli Lilly and Company, Indianapolis, IN

Dustin French, PhD
Health Economist, VISN 8 Patient Safety Center, Tampa, FL

Arnold Friede, JD
Senior Corporate Counsel, Pfizer; Former Associate Chief Counsel, FDA, New York, NY

John (Jack) Garvey
Vice President, Compliance & Quality Management, THE WEINBERG GROUP, Princeton, NJ

Gary Giampetruzzi, Esq.
Senior Corporate Counsel, Deputy Compliance Officer, International Investigations and Programs, Pfizer, New York, NY

Stephen A. Goldman, MD, FAPM, DFAPA
Managing Member, Stephen A. Goldman Consulting Services, Former Medical Director, MedWatch, FDA, Morris Plains, NJ

Linda Horton, JD
Partner, Hogan & Hartson; Former Director of International Policy and Deputy Chief Counsel for Regulations, FDA, Brussels, Belgium and Washington, DC

John Kamp, JD, PhD
Executive Director, Coalition for Healthcare Communication; Of Counsel, Wiley Rein, Washington, DC

Anjali Kataria
Co-Founder, FDA-Conformia CRADA Study, Principal Investigator, Sunnyvale, CA

Keith Korenchuk, JD, MPH
Of Counsel, Covington & Burling, Washington, DC

Greg Koski, MD, PhD, CPI
Associate Professor of Anesthesia, Senior Scientist, Institute for Health Policy, Massachusetts General Hospital, Partners Health Care System, Harvard Medical School, Former Director, Office for Human Research Protections, Office of Public Health and Science, Office of the Secretary, HHS, Boston, MA

Daniel Kracov, JD
Partner, Co-Head, Pharmaceutical and Medical Device Practice, Arnold & Porter, Washington, DC

Michael Labson, JD
Partner, Covington & Burling, Washington, DC

Geoff Levitt, Esq.
Vice President and Chief Counsel, Regulatory and Research, Wyeth Pharmaceuticals, Collegeville, PA

Douglas Long, MBA
Vice President, Industry Relations, IMS Health, Totowa, NJ

Claudio Pincus
President, The Quantic Group, Livingston, NJ

Peter Pitts
President, Center for Medicines in the Public Interest; Senior Vice President for Global Health Affairs, Manning, Selvage & Lee; Former Associate Commissioner for External Relations, FDA, New York, NY

R. Owen Richards
President, Quantic Regulatory Services, LLC, Livingston, NJ

Linda Rivero
President, Voice of Persuasion, Alexandria, VA

Nancy Singer
President of Compliance-Alliance; Former Prosecutor, U.S. Department of Justice, Washington, DC

Thomas Sobol, Esq.
Managing Partner, Hagens Berman Sobol Shapiro, Cambridge, MA

Kristina Spitler
Training Manager, Almac Clinical Services, Durham, NC

Alex Sugerman-Brozan
Director, Prescription Access Litigation (PAL) Project, Boston, MA

Ivan Wasserman
Partner, Manatt, Phelps & Phillips, LLP, Washington, DC


THE VENUES AT HARVARD

SPONSORED BY:








GRANTORS:
BRONZE


WELCOME MESSAGE FROM ARTHUR MILLER

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

"It is my pleasure to welcome attendees of the FDA Symposium to the campus of Harvard University. I hope that you will take advantage of this unique experience to contemplate strategic issues in patient safety, health care quality enhancement and medical errors reduction with the assistance of the first rate Symposium faculty."

FEATURED TRACKS
  • Advertising, Promotion and Compliance
  • Drug Safety and Risk Management
  • Innovative Compliance Strategies
  • Intellectual Property and Generic Competition
  • Pharma Product Development and Clinical Trials


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