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Washington Marriott Wardman Park

Feb 27, 2014 7:00 AM - Feb 28, 2014 4:30 PM

2660 Woodley Road, NW, , Washington, DC 20008 , USA

Marketing Pharmaceuticals 2014: Regulating Drug Marketing in the Ever-Changing Regulatory/Legal/Health Care Environment

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Session 7 Breakout 2 - Supporting Successful Product Launches

Session Chair(s)

Mark Gaydos

Mark Gaydos

Global Head, Advertising & Promotion, Global Regulatory Affairs

Sanofi, United States

A new product launch sets the tone and trajectory for that product’s future commercial success. This session will examine permissible and prudent communications a company can engage in prior to approval, while examining the strategic and operational aspects of soliciting advisory comments, as well as mandatory Subpart E & H preclearance, for core launch promotional materials. The session will also address how companies can move forward with an immediate product launch using key materials while awaiting receipt of FDA comments on core launch materials.

Speaker(s)

Gina L. Vestea, PharmD

Panelist

Gina L. Vestea, PharmD

Sanofi US Inc., United States

Director, US Regulatory Affairs Marketed Products

Barri Falk, MS

Panelist

Barri Falk, MS

Deloitte Consulting, LLP, United States

Director, Life Sciences and Healthcare Strategy

Mark Meltz, JD

Panelist

Mark Meltz, JD

Biogen Idec MA Inc., United States

Associate General Counsel, Corporate

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