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Boston Convention and Exhibition Center

23 jun 2013 8:30 a.m. - 27 jun 2013 12:45 p.m.

415 Summer Street, , Boston, MA 02210 , USA

DIA 2013 49th Annual Meeting: Advancing Therapeutic Innovation and Regulatory Science

Session Chair(s)

Mary K. Sendi, PHARMD

Mary K. Sendi, PHARMD

Medical Information & Review, Global US Regional Lead

Pfizer, United States

Learning Objective : Discuss FDA’s regulatory and statutory framework governing medical and scientific communications; Discuss comments to "Draft Guidance for Unsolicited Requests for Off-Label Use and Docket No FDA-2011-N-0912"; Discuss how industry is ensuring health care professionals have access to credible medical information needed for informed treatment decisions.

Speaker(s)

Melissa L. Harris, PHARMD

Panelist

Melissa L. Harris, PHARMD

Bristol-Myers Squibb Company, United States

Worldwide Medical Lead HCV

D. Stuart  Sowder, JD, PHARMD, MBA

Panelist

D. Stuart Sowder, JD, PHARMD, MBA

Pfizer Holdings, United States

Vice President, Compliance Lead, Asia, Pacific, Africa, Middle East

Jeffrey  Francer, JD, MPA

Panelist

Jeffrey Francer, JD, MPA

Eli Lilly and Company, United States

Vice President, Head of International Regulatory Affairs and Global Regulatory P

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