The FDA Symposium

THE FOURTH ANNUAL FDA REGULATORY SYMPOSIUM
Onsite: September 30 - October 2, 2009 at
Renaissance Washington DC Hotel
Online: Live and Archived for 6 Months

MOVING FROM HARVARD TO DC IN 2009 TO ADDRESS THE ISSUES OF THE NEW ADMINISTRATION AND HEALTH REFORM

FDA SYMPOSIUM IS A

GRANTORS

BRONZE

SPEAKER PRESENTATION PROPOSALS

Speaker/Presentation Proposals for the FDA Symposium may be submitted through our online form.
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FEATURING

Implications of the New FDA Leadership: The Agency's Evolving Agenda

Drug Safety vs. Safe Use: How FDA's Safe Use Initiative will Impact Industry

The Impact of Comparative Effectiveness and Health Outcomes on the FDA and Industry

The Evolution of FDA'S Risk Evaluation Mitigation Strategies (REMS) and the Future of Drug Safety

How Healthcare Reform will Impact Pharma: Opportunities and Challenges

New Trends in FDA Enforcement, Criminal Prosecution, and Federal Preemption

Off-Label Promotion: Why Scrutiny of Off-Label Use is not Going Away

Understanding the Impact of Social Media and New Media

Congressional Leaders and Top Aides Address FDA/Drug Marketing Legislation

Competing Views on the Proper Role of Industry Collaboration

SPONSORED BY

THE FOURTH NATIONAL FDA REGULATORY SYMPOSIUM September 30 - October 2, 2009
ONSITE Renaissance Washington DC Hotel Washington, DC	OR	ONLINE In your own office or home live via the Internet with 24/7 access for six months

FEATURING KEYNOTE ADDRESS BY

Margaret A. Hamburg, MD
Commissioner of Food and Drugs, Food and Drug Administration, Former Commissioner, Department of Health and Mental Hygiene, New York City, Silver Spring, MD

MAJOR ADDRESSES BY

Thomas W. Abrams, RPh, MBA
Director, Division of Drug Marketing, Advertising, and Communications, Center for Drug Evaluation and Research (CDER), Food and Drug Administration, Silver Spring, MD

Robert Temple, MD
Associate Director for Medical Policy, Center for Drug Evaluation and Research, Food and Drug Administration, Silver Spring, MD

Janet Woodcock, MD
Director, Center for Drug Evaluation and Research (CDER), Food and Drug Administration, Silver Spring, MD

LEADING LEGAL AND REGULATORY PROFESSIONALS

Ed Berg, Esq. Deputy General Counsel, Sanofi-Aventis, Bridgewater, NJ	Marc L. Berger, MD Vice President, Global Health Outcomes, Eli Lilly and Company, Indianapolis, IN	Cathryn M. Clary, MD, MBA Vice President, US External Medical Affairs, Pfizer, New York, NY
John Ferguson, MD, PhD Vice President and Global Head, Pharmacovigilance, Vaccines and Diagnostics, Novartis Pharmaceuticals, Florham Park, NJ	Rekha Garg, MD Executive Director, Global Regulatory Affairs and Safety, Amgen, San Francisco, CA	Elisabeth M. George Vice-President , Quality, Regulatory, Sustainability & Product Security, Philips Medical Systems, Inc., Andover, MA

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

John Moriarty, Esq.
Senior Vice President, Legal/Commercial Operations, Elan, Former Executive Director & Associate General Counsel, Amgen, Former Special Assistant United States Attorney, San Francisco, CA

Michael Morton
Senior Director Global Regulatory Affairs, Medtronic Corporation, Minneapolis, MN

THE FOLLOWING FORMER FDA CHIEF COUNSEL

Sheldon Bradshaw, Esq.
Partner and Co-chair, Food and Drug Practice Group, Hunton & Williams LLP, Former Chief Counsel 2005 - 2007, Office of the General Counsel, Food and Drug Administration, Washington, DC

Nancy L. Buc, Esq.
Partner, Buc & Beardsley, Former Chief Counsel 1980-1981, Office of the General Counsel, Food and Drug Administration, Washington, DC

Richard Cooper, Esq.
Partner, Williams & Connolly, LLP, Former Chief Counsel 1977 - 1979, Office of the General Counsel, Food and Drug Administration, Washington, DC

Peter Barton Hutt, Esq.
Senior Counsel, Covington & Burling, Former Chief Counsel 1972 - 1975, Office of the General Counsel, Food and Drug Administration, Washington, DC

Gerald F. Masoudi, Esq.
Partner, Covington & Burling, Former Chief Counsel 2007 - 2009, Office of the General Counsel, Food and Drug Administration, Deputy Assistant Attorney General, International, Policy and Appellate Matters, Antitrust Division, US Department of Justice, Washington, DC

LEADING FDA EXPERTS AND COUNSEL

Howard l. Dorfman, Esq. Counsel, Ropes & Gray, Former former Chief Legal Officer, Pharmaceutical Division, Bayer Healthcare LLC, Former Counsel, US Medicines Group, Bristol-Myers Squibb, New York, NY	Arnold I. Friede, Esq. Counsel, McDermott Will & Emery LLP, Former Chief Counsel, Office of the General Counsel, Food and Drug Administration, Washington, DC	Scott Gottlieb, MD Resident Fellow, American Enterprise Institute, Former Commissioner for Medical and Scientific Affairs, Food and Drug Administration, Washington, DC
John F. Kamp, JD, PhD Executive Director, Coalition for Healthcare Communication, Of Counsel, Wiley Rein, Washington, DC	Meredith Manning, Esq. Partner and Co-director, Pharmaceutical and Biotechnology Practice Group, Hogan & Hartson, Former Assistant U.S. Attorney, Civil Division, Former Associate Chief Counsel, FDA, Washington, DC	Claudio Pincus President, The Quantic Group, Ltd., Livingston, NJ

Wayne L. Pines
President, Regulatory Services and Healthcare, APCO Worldwide, Former Associate Commissioner for Public Affairs, Food and Drug Administration, Washington, DC

Peter Pitts
Director, Center for Medicines in the Public Interest (CAMPY), Director of Global Healthcare, Porter Novelli, Washington, DC

Robin Strongin
President and Chief Executive Officer, Amplify Public Affairs, Washington DC

AND A SPECIAL PRECONFERENCE SESSION ON DANGEROUS DOCUMENTS: FINDING LAND MINES IN YOUR FDA REPORTS AND EMAILS

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

THE TIME IS NOW FOR NEW, EFFICIENT AND COST EFFECTIVE ALTERNATIVES
TO TRADITIONAL LEARNING APPROACHES

A variety of forces - the nation's economic crisis, costly and difficult air travel, the mandate for cost efficiency in healthcare, the proliferation of greater Internet bandwidth, the emergence of the popularity of online video via You Tube, and the explosion of online training in the health sector - has come together to create both a dramatic need and an extraordinary opportunity for innovative approaches to sharing new ideas and best practices. This Symposium offers not only traditional conference attendance, but also the opportunity to attend the event live and archived online.

How can we be expected to reform the nation's health system if we can not reform the way we do our own business?

ATTENDANCE OPTIONS

TRADITIONAL ONSITE ATTENDANCE

Simply register, travel to the conference city and attend in person.

Pros: subject matter immersion; professional networking opportunities; faculty interaction

INTERNET INTERFACE SAMPLE
Click here for a sample stream

LIVE AND ARCHIVED INTERNET ATTENDANCE

Watch the conference in live streaming video over the Internet and at your convenience at any time 24/7 for the six months following the event.

The archived conference includes speaker videos and coordinated PowerPoint presentations.

Pros: Live digital feed and 24/7 Internet access for next six months; Accessible in office, at home or anywhere worldwide with Internet access; Avoid travel expense and hassle; No time away for the office