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Product Communications in the Preapproval Phase
Program Code:
270
Date:
Tuesday, June 25, 2013
Time:
4:00 PM to 5:30 PM
EST
CHAIR
:
Mark Gaydos,
(SCHNON), Vice President, US Regulatory Affairs Marketed Products,
Sanofi US, United States
Mr. Gaydos develops and implements regulatory strategies for sanofi-aventis’ oncology portfolio and US Submissions group. He also serves as regulatory lead on its Social Media Task Force. He has held positions of increasing responsibility with Pfizer, Amgen, Block Drug & Whitehall-Robins Healthcare.
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SPEAKER
(S):
Mark Gaydos,
(SPKNON), Vice President, US Regulatory Affairs Marketed Products,
Sanofi US, United States
Mr. Gaydos develops and implements regulatory strategies for sanofi-aventis’ oncology portfolio and US Submissions group. He also serves as regulatory lead on its Social Media Task Force. He has held positions of increasing responsibility with Pfizer, Amgen, Block Drug & Whitehall-Robins Healthcare.
|
Dennis Lawrence Nosco,
PhD,RAC (SPKNON), Senior Director, Global Labeling, Regulatory Affairs,
Mallinckrodt, United States
He has 12 years of experience in Regulatory, 9 years of experience in ad/promo review for Mallinckrodt’s pharmaceutical products and medical devices and was most recently Director, Regulatory Ad/Promo at Mallinckrodt before he was promoted to his current position in 2011.
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Alan R Bennett, JD (SPKNON), Managing Partner, DC Office, Ropes & Gray, 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 preapproval 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 preapproval disease awareness campaign? What are the pros and cons of a "coming soon" campaign?