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Current Regulatory Landscape Impacting Medical and Scientific Communications
Session Chair(s)
Mary K. Sendi, PharmD
MI Regional Lead North America
Pfizer Inc, United States
This session will address how FDA regulatory guidance documents affect the pharmaceutical industry, impacting how externally-facing medical functions communicate medical and scientific information to health care professionals and consumers.
This session has been developed by the Medical Communications Community.
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Discuss FDA’s regulatory and statutory framework governing medical and scientific communications; Discuss comments to "Draft Guidance for Unsolicited Requests for Off-Label Use and Docket No FDA-2011-N-0912"; Discuss how industry is ensuring health care professionals have access to credible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)
Panelist
Melissa L. Harris, PharmD
Bristol-Myers Squibb Company, United States
Worldwide Medical Lead HCV
Panelist
D. Stuart Sowder, JD, PharmD, MBA
Pfizer Holdings, United States
Vice President, Compliance Lead, Asia, Pacific, Africa, Middle East
Panelist
Jeffrey K. Francer, JD
Eli Lilly and Company, United States
Vice President, Head of Global Regulatory Policy and Strategy
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