Product Communications in the Pre-Approval Phase

Day & Time:
February 21, 10:30AM - 12:00PM

Type:
Session

Title:
Product Communications in the Pre-Approval Phase

Chair(s):
Mark Gaydos
Vice President, US Regulatory Affairs Marketed Products
Sanofi, United States

Description:
This session will focus on the types of information a company might consider communicating about its research efforts, pipeline products and corresponding development programs. Select topics include: What, how, and to whom can companies communicate about research efforts and pipeline products while avoiding allegations of pre-approval or off-label promotion? What and when can a company proactively communicate about planned and ongoing clinical trials? What are the parameters a company should observe when developing a pre-approval disease awareness campaign? What are the pros and cons of a coming soon campaign?

Presentation(s) & Speaker(s):
Speakers
Leah Palmer, PharmD
Executive Director, Regulatory Promotion
Amgen Inc., United States

Speakers
Dennis Lawrence Nosco, PhD,RAC
Senior Director, Global Labeling, Regulatory Affairs
Mallinckrodt, The Pharmaceuticals Business of Covidien , United States

Speakers
Alan R Bennett, JD
Managing Partner, DC Office
Ropes & Gray, United States