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National Pharma Audioconference: The FDA's Internet Ad Warnings: The Implications for Pharma's Move into Social Media

Wednesday, May 20, 2009

1:00 pm - 2:30 pm (Eastern)
12:00 pm - 1:30 pm (Central)
11:00 am - 12:30 pm (Mountain)
10:00 am - 11:30 am (Pacific)


AUDIOCONFERENCE FACULTY

Matthew Holt
Editor, The Health Care Blog, Chair, Health 2.0 Conference, San Francisco, CA

Meredith Manning, Esq.
Partner and Co-director, Pharmaceutical and Biotechnology Practice Group, Hogan & Hartson, Former Assistant U.S. Attorney, Civil Division , US Attorney's Office, Former Associate Chief Counsel, Office of the General Counsel, Food and Drug Administration, Washington, DC

Michael Misocky, Esq.
President, Misocky Consulting Group, Former Assistant Vice President and Deputy Compliance Officer, ImClone Systems, Former Regulatory Review Officer, Division of Drug Marketing, Advertising, and Communications (DDMAC), Food and Drug Administration, Washington, DC



John B. Moriarty, Jr., Esq.
Senior Vice President -- Law, Elan Pharmaceuticals, Inc., South San Francisco, CA



Matthew Hay
Editor, Rx Compliance Report, Washington, DC (Moderator)


AUDIOCONFERENCE OVERVIEW

As new online media evolve at an explosive pace, the FDA's inability to clarify how existing regulations apply to online advertising is becoming increasingly problematic for drug companies. Former FDA and DOJ attorney Meredith Manning says pharma companies using sites featuring user-generated content (YouTube, Wikipedia, blogs), social networking sites (Facebook, LinkedIn, MySpace), and professional networking sites (Sermo, Socrato) must carefully weigh a number of risks. On Wednesday, May 20, Manning will be joined my former FDA attorney Michael Misocky and social media expert Matthew Holt to assess both the risks and the opportunities presented by today's dynamic new marketing environment.


DOJ VETERAN SAYS PHARMA ONLINE ADVERTISING IS LIKELY TARGET OF FEDERAL INVESTIGATIONS

Online drug advertising is a likely target of federal investigations, according to Margaret Hutchinson, Assistant U.S. Attorney in the Eastern District of Pennsylvania. "There is a new focus on how accurate your online advertising is," she recently warned the industry, including what portion of the disclaimers included in direct-to-consumer (DTC) advertising must be included as part of any online advertising. "Those can be an interesting area for potential for problems in the future," said Hutchinson.

On Wednesday, May 20, former FDA and DOJ attorney Meredith Manning, former FDA attorney Michael Misocky, and Elan's John Moriarty will examine the enforcement environment facing drug and device companies in the increasingly important areas of Internet advertising and social media and offer strategies for minimizing the risks in these areas. In addition, social media expert Matthew Holt will offer a fresh assessment of industry trends and potential opportunities in this rapidly evolving media.


AUDIOCONFERENCE AGENDA
The Audioconference agenda is set forth in Eastern Daylight Time below:
1:00 pm Welcome and Introductory Remarks
Matthew Hay (Moderator)
1:05 pm Understanding the Emerging Social Media Environment: Where Things Stand and What The Future Holds
Matthew Holt
1:20 pm An Assessment of FDA's 14 Warning Letters in the Framework of the Agency's Enforcement History
Meredith Manning, Esq.
1:35 pm How to Apply FDA's Advertising Rules to the Emerging Social Media Environment
Michael Misocky, Esq.
1:50 pm How to Implement Effective Controls on a Company-Wide Basis
John B. Moriarty, Jr., Esq.
2:05 pm Questions & Answers
Matthew Hay (Moderator)
2:30 pm Audioconference Adjournment

SAVE THE DATE
THIRD INTERNATIONAL PHARMACEUTICAL REGULATORY AND COMPLIANCE CONGRESS
Sponsored by Pharmaceutical Compliance Forum
May 28 - 29, 2009
Rome, Italy
www.InternationalPharmaCongress.com
FOURTH ANNUAL MEDICAL DEVICE REGULATORY, REIMBURSEMENT AND COMPLIANCE CONGRESS
November 9 - 11, 2009
JW Marriott Hotel
Washington, DC
www.DeviceCongress.com
TENTH ANNUAL PHARMACEUTICAL REGULATORY AND COMPLIANCE CONGRESS
Sponsored by Pharmaceutical Compliance Forum
November 11 - 13, 2009
JW Marriott Hotel
Washington, DC
www.PharmaCongress.com


SPONSORED BY:











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