FDA Regulatory and Compliance Symposium
FDA Regulatory and Compliance Symposium
 FDA Regulatory and Compliance Symposium
 FDA Regulatory and Compliance Symposium
FDA Regulatory and Compliance Symposium
FDA Regulatory and Compliance Symposium
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FDA Regulatory and Compliance Symposium
FDA Regulatory and Compliance Symposium
FDA Regulatory and Compliance Symposium

FDA Regulatory and Compliance 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

WITH SPECIAL PRESENTATIONS ON
  • FDA's Regulatory Agenda: Margaret Hamburg, FDA Commissioner
  • Comparative Effectiveness: Robert Temple, CDER, FDA
  • FDA's Safe Use Initiative: Janet Woodcock, CDER, FDA
  • FDA Enforcement: Tom Abrams, CDER, FDA
  • FDA's Device Approval and Safety Initiatives, Jonathan Sackner Bernstein, MD, CDRH, FDA
  • The Agency's Approach to Social Media: Sanjay Koyani, FDA
  • Five former FDA Chief Counsel to Address Off-Label, Preemption, Enforcement and the Future of the FDA

GRANTORS
SILVER
FDA Regulatory and Compliance Symposium

BRONZE
FDA Regulatory and Compliance Symposium
 FDA Regulatory and Compliance Symposium
FDA Regulatory and Compliance Symposium
FDA SYMPOSIUM ONLINE ARCHIVE LOG IN
Click here to log into FDA Symposium video archive.

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
    FDA Regulatory and Compliance Symposium
    		 FDA Regulatory and Compliance Symposium
    FDA Regulatory and Compliance Symposium

    FDA SYMPOSIUM IS A
    FDA Regulatory and Compliance Symposium
    THE FDA SYMPOSIUM CONTENT IS NOW AVAILABLE IN VARIOUS POST CONFERENCE FORMATS

    The FDA Symposium conference content is now available in a variety of formats.

    You may purchase the Symposium streaming content in the following formats: Data DVD, iPod™ Touch, Flash Drive or online archive (6 months). You may also purchase individual presentations in an online archive (6 months) format.

    YOU CAN PURCHASE JUST THE FDA SYMPOSIUM CONTENT AS FOLLOWS:

    iPod Touch of 2009 FDA Symposium Presentations today!
    $429
    Order Now
    Data DVD of 2009 FDA Symposium Presentations today!
    $245
    Order Now
    Flash Drive of 2009 FDA Symposium Presentations today!
    $245
    Order Now
    Online Archive of 2009 FDA Symposium Presentations today!
    Complete conference: $395
    Order Now

    FINALLY YOU MAY PURCHASE FDA SYMPOSIUM INDIVIDUAL PRESENTATIONS:
    Click here to purchase individual presentations for $59.95 in online archive format (6 months of access - 24/7).

    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
    FDA Regulatory and Compliance Symposium
    		FDA Regulatory and Compliance Symposium
    FEATURING KEYNOTE ADDRESS BY
    FDA Regulatory and Compliance Symposium
    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

    FDA LEADERS
    FDA Regulatory and Compliance Symposium
    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    		 FDA Regulatory and Compliance Symposium
    Jonathan Sackner Bernstein, MD
    Associate Center Director, Post Market Operations, Center for Devices and Radiological Health (CDRH), Food and Drug Administration, Silver Spring, MD
    FDA Regulatory and Compliance Symposium

    Sara F. Goldkind, MD
    Senior Bioethicist, Food and Drug Administration, Rockville, MD
    FDA Regulatory and Compliance Symposium
    Sanjay J. Koyani
    Director, FDA Web Communications, Office of Public Affairs, Food and Drug Administration, Silver Spring, MD    		 FDA Regulatory and Compliance Symposium
    Robert Temple, MD
    Associate Director for Medical Policy, Center for Drug Evaluation and Research, Food and Drug Administration, Silver Spring, MD

    FDA Regulatory and Compliance Symposium

    Deborah Wolf, JD
    Director, Regulations Staff, Office of Communication, Education and Radiation Programs, Center for Devices and Radiological Health, Food and Drug Administration, Rockville, MD    		 FDA Regulatory and Compliance Symposium
    Janet Woodcock, MD
    Director, Center for Drug Evaluation and Research (CDER), Food and Drug Administration, Silver Spring, MD

    LEADING LEGAL AND REGULATORY PROFESSIONALS
    FDA Regulatory and Compliance Symposium

    Ed Berg, Esq.
    Deputy General Counsel, Sanofi-Aventis, Bridgewater, NJ    		 FDA Regulatory and Compliance Symposium
    Marc L. Berger, MD
    Vice President, Global Health Outcomes, Eli Lilly and Company, Indianapolis, IN    		 FDA Regulatory and Compliance Symposium
    John Ferguson, MD, PhD
    Vice President and Global Head, Pharmacovigilance & Medical Safety, Novartis Vaccines & Diagnostics, Cambridge, MA
    FDA Regulatory and Compliance Symposium
    Rekha Garg, MD
    Executive Director, Global Regulatory Affairs and Safety, Amgen, Thousand Oaks, CA    		 FDA Regulatory and Compliance Symposium
    Elisabeth M. George
    Vice-President , Quality, Regulatory, Sustainability & Product Security, Philips Medical Systems, Inc., Andover, MA    		 FDA Regulatory and Compliance Symposium
    Elizabeth V. Jobes, Esq.
    Chief Compliance Officer, Adolor Corporation, Former Senior Director, Global Compliance Officer, Cephalon, Inc., Former Assistant District Attorney, Philadelphia District Attorney's Office, Exton, PA

    FDA Regulatory and Compliance Symposium
    Geoffrey Levitt, Esq.
    Vice President and Chief Regulatory Counsel, Wyeth Pharmaceuticals, Collegeville, PA    		 FDA Regulatory and Compliance Symposium
    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
    FDA Regulatory and Compliance Symposium
    Michael Morton
    Senior Director Global Regulatory Affairs, Medtronic Corporation, Minneapolis, MN    		 FDA Regulatory and Compliance Symposium
    Marc Wilenzick, Esq.
    Assistant General Counsel, Pfizer, Former Assistant Chief Counsel, Food and Drug Administration, New York, NY

    THE FOLLOWING FORMER FDA CHIEF COUNSEL
    FDA Regulatory and Compliance Symposium
    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    		 FDA Regulatory and Compliance Symposium
    Nancy L. Buc, Esq.
    Partner, Buc & Beardsley, LLP, Former Chief Counsel 1980-1981, Office of the General Counsel, Food and Drug Administration, Washington, DC    		 FDA Regulatory and Compliance Symposium
    Richard Cooper, Esq.
    Partner, Williams & Connolly, LLP, Former Chief Counsel 1977 - 1979, Office of the General Counsel, Food and Drug Administration, Washington, DC
    FDA Regulatory and Compliance Symposium
    Peter Barton Hutt, Esq.
    Senior Counsel, Covington & Burling, Former Chief Counsel 1972 - 1975, Office of the General Counsel, Food and Drug Administration, Washington, DC    		 FDA Regulatory and Compliance Symposium
    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
    FDA Regulatory and Compliance Symposium
    Stuart Altman
    Partner, Washington DC, Hogan & Hartson, Washington DC    		 FDA Regulatory and Compliance Symposium
    Scott Bass
    Partner and Chair, Global Life Sciences Team, Sidley Austin LLP, Washington, DC    		 FDA Regulatory and Compliance Symposium
    Charles B. Cairns, MD, FACEP, FAHA
    Professor and Chair, Department of Emergency Medicine, UNC School of Medicine, Chapel Hill, NC
    FDA Regulatory and Compliance Symposium
    Eric G. Campbell, PhD
    Associate Professor, Harvard University, Institute for Health Policy, Committee Member, Conflict of Interest in Medical Research, Education and Practice, Institute of Medicine, Boston, MA    		 FDA Regulatory and Compliance Symposium
    James H. Davidson, Esq.
    Partner, Polsinelli Shughart PC, Founder, Davidson & Company, Washington, DC    		 FDA Regulatory and Compliance Symposium
    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
    FDA Regulatory and Compliance Symposium
    Merrill Goozner
    Publisher, Gooznews.com and Heath Tech Review, Author, The $800 Million Pill: The Truth Behind the Cost of New Drugs, Former Director, Integrity in Science Project, Center for Science in the Public Interest, Washington, DC    		 FDA Regulatory and Compliance Symposium
    Scott Gottlieb, MD
    Resident Fellow, American Enterprise Institute, Former Commissioner for Medical and Scientific Affairs, Food and Drug Administration, Washington, DC    		 FDA Regulatory and Compliance Symposium
    Steven E. Irizarry, Esq.
    Senior Vice President, Capitol Hill Consulting Group, Former Senior Health Counsel, Special Committee on Aging, United Sates Senate, Washington, DC
    FDA Regulatory and Compliance Symposium
    John F. Kamp, JD, PhD
    Executive Director, Coalition for Healthcare Communication, Of Counsel, Wiley Rein, Washington, DC    		 FDA Regulatory and Compliance Symposium
    Coleen Klasmeier, Esq.
    Partner, and Chair, FDA Regulatory Practice Group, Sidley Austin LLP, Former Staff Attorney and Special Assistant to the Chief Counsel, Food and Drug Administration, Washington, DC    		 FDA Regulatory and Compliance Symposium
    Amanda Makki
    Legislative Assistant, Health Care - Office of Senator Lisa Murkowski (R/AK), United States Senate, Washington, DC
    FDA Regulatory and Compliance Symposium
    Stephen Paul Mahinka, Esq.
    Partner and Chair, Life Sciences Practice, Morgan, Lewis & Bockius LLP, Washington, DC    		 FDA Regulatory and Compliance Symposium
    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    		 FDA Regulatory and Compliance Symposium
    Christina M. Markus, Esq.
    Partner and Deputy Chair, FDA & Life Sciences Group, King & Spalding, Washington, DC
    FDA Regulatory and Compliance Symposium
    Karen J. Maschke, PhD
    Editor, IRB: Ethics and Human Research, The Hastings Institute, New York, NY    		 FDA Regulatory and Compliance Symposium
    Jack Mitchell
    Chief of Oversight and Investigations, Special Committee on Aging, United Sates Senate, Former CNN Reporter, Washington, DC    		 FDA Regulatory and Compliance Symposium
    Claudio Pincus
    President, The Quantic Group, Ltd., Livingston, NJ
    FDA Regulatory and Compliance Symposium
    Wayne L. Pines
    President, Regulatory Services and Healthcare, APCO Worldwide, Former Associate Commissioner for Public Affairs, Food and Drug Administration, Washington, DC    		 FDA Regulatory and Compliance Symposium
    Peter Pitts
    Director, Center for Medicines in the Public Interest (CAMPY), Director of Global Healthcare, Porter Novelli, Washington, DC    		 FDA Regulatory and Compliance Symposium
    Nikki Reeves, JD, MPA
    Partner, FDA & Life Sciences Practice Group, King & Spalding, Washington, DC
    FDA Regulatory and Compliance Symposium
    Kevin Schulman, MD
    Associate Director, Duke Clinical Research Institute, Professor of Medicine, Director, Center for Clinical and Genetic Economics, Vice-chair for Business Affairs, Department of Medicine, School of Medicine, Duke University, Director, Health Sector Management Program, Fuqua School of Business, Durham, NC    		 FDA Regulatory and Compliance Symposium
    Robin Strongin
    President and Chief Executive Officer, Amplify Public Affairs, Creator of the Disruptive Women in Health Care blog, Washington DC    		 FDA Regulatory and Compliance Symposium
    Andrew C. von Eschenbach, MD
    Senior Advisor. Greenleaf Health, Former Commissioner, Food and Drug Administration, Former Director, National Cancer Institute, Washington, DC

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

    		 FDA Regulatory and Compliance Symposium




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    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

    		 FDA Regulatory and Compliance Symposium

    FDA Regulatory and Compliance Symposium

    INTERNET INTERFACE SAMPLE

    FDA Regulatory and Compliance Symposium
    Click here for a sample stream
    		FDA Regulatory and Compliance Symposium
    FDA Regulatory and Compliance Symposium
    FDA Regulatory and Compliance Symposium
    Overview | Agenda/Faculty Materials | Brochure | Promotional Opportunities
    Administration | Speaking Proposals | Past Events | Contact Us | Home
    		FDA Regulatory and Compliance Symposium
    FDA Regulatory and Compliance Symposium


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