Supporting Successful Product Launches

Day & Time:
February 28, 2:00PM - 3:15PM


Supporting Successful Product Launches

Mark Gaydos
Vice President, US Regulatory Affairs Marketed Products
Sanofi US, 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.

Presentation(s) & Speaker(s):
Gina L. Vestea, PharmD
Director, US Regulatory Affairs Marketed Products
Sanofi US Inc., United States

Barri Falk, MS
Director, Life Sciences and Healthcare Strategy
Deloitte Consulting, LLP, United States

Mark Meltz, JD
Associate General Counsel, Corporate
Biogen Idec MA Inc., United States

© 2014