DESCRIPTION

Highly-regulated drug, device and other companies subject to FDA’s jurisdiction have embraced using the internet to promote their products. And many have extended their internet strategies to using social media such as Facebook, Twitter, YouTube, Pinterest and even Tumblr to convey their messages. In so doing, however, those firms have encountered an FDA that, in the firms’ minds, is stuck in the 20th century on how it regulates the internet. This webinar will detail how FDA approaches the regulation of messaging on the Internet, with a particular emphasis on the use of social media. Attendees will learn the agency’s views on the extent of its authority to regulate the internet, with specific examples of firms that have run afoul of FDA’s views on proper internet promotional activities. We also will explore some best practices that firms should adopt to make sure that they stay in FDA’s good graces while taking advantage of these powerful and now not-so-new media outlets. Finally, if published prior to the webinar, we also will explore FDA’s long-awaited guidance document on the internet and social media.

Why you should attend:

Executives (VPs, Directors, Managers) and other professionals involved in implementing the use of social media at FDA-regulated companies. In particular, professionals from these functional arenas:

Sales, Marketing, Quality Assurance, Legal, Regulatory, Compliance, Medical Affairs, Clinical Affairs, Clinical Operations, Investor Relations, Corporate Communications

Areas Covered In the Seminar:

FDA legal authority over the internet? Why FDA does not see the internet as needing special rules – and the absence of agency guidance to date and the potential for guidance to eventually be issued. When is a web site advertising or labeling or both and why does it matter? Controls on testimonials and sponsored web and social media sites. Being careful on what you “like” on social media site regarding your products! What is “off-label” and whatever happened to the First Amendment?

Webinar includes:

Copies of warning letters referred to in presentation will be available following the webinar. Q/A Session with the Expert to ask your question A copy of the PowerPoint slides 60 Minutes Live Presentation Attendance Of Certificate