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Omni Shoreham Hotel

Feb 23, 2017 7:00 AM - Feb 24, 2017 5:00 PM

2500 Calvert Street NW, , Washington, DC 20008 , USA

Advertising and Promotion Regulatory Affairs Conference

Session 5: Navigating the Murky Waters of Off-Label Communications: Promotion, Commercial Speech and Scientific Exchange

Session Chair(s)

Mark  Gaydos

Mark Gaydos

Former Global Head, Advertising & Promotion, Global Regulatory Affairs

Sanofi, United States

In recent years, the already challenging issues associated with sponsors’ off-label communications have become even more complicated. Following recent court decisions favoring less government restriction of commercial speech in this area, industry and other interested parties anxiously await FDA’s broader policy position, which it committed to comprehensively reviewing in the wake of these First Amendment cases. In the meantime, and also considering the perspectives presented at FDA’s November 2016 public hearing, we will consider where companies might consider altering their traditional policies and where they will want to continue exercising great caution.

Speaker(s)

Mark  Gaydos

Speaker

Mark Gaydos

Sanofi, United States

Former Global Head, Advertising & Promotion, Global Regulatory Affairs

Michael S. Labson, JD

Speaker

Michael S. Labson, JD

Covington & Burling LLP, United States

Partner

Jess  Amchin

Speaker

Jess Amchin

Jess Amchin Consulting, LLC, United States

Michael  Zilligen

Speaker

Michael Zilligen

Ogilvy Health, United States

Market Access Practice Lead

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