Live blogging the eXL Digital Pharma conference, from Princeton, NJ. This second day will focus on the Regulatory environment.
Mark Gaydos, Senior Director US Regulatory Affairs Marketed Products, Sanofi-Aventis: Mobilizing your Company for more complete Web 2.0
– Establish a Dedicated Team – need to have representation from all stakeholders (Commercial/Mkting, PR, Reg, Legal, etc.). It’s good for Reg key players to look ahead, and anticipate, and have strategies in place.
– Non-marketers need to think like Marketers – Just Don’t Say “No”! Imagine possibilities. Partner, not oppose.
– Identify Initiatives to be Pursued – advertise on soc med website. Host moderated community. Host moderated KOL blog. Conversation monitoring. Start small and develop a roadmap for moving forward. btw, FDA’s not waiting; they’re using soc med (have own YouTube channel).
– Gain Sr. Mgmt. Approval – know your risks, and have credible/defensible interpretations and policies in place.
– Move forward in Stages “try it on,” learn, evolve, adjust.
– Progress…with Caution
Example of FDA warning letter to Shire for Ty Pennington on YouTube video – but soc med not the problem, it was bread and butter violations of fair balance, etc.