FDA Guidance on Social Media: Questions Answered and Unanswered

Date: October 8, 2014
Time: 1pm - 2:30pm EDT
Duration: 90 Minutes - Online
Price: $299 - Introductory Rate

Course Description:

Beginning with FDA’s 2009 hearings on the Internet and social media platforms, industry has been anxiously awaiting guidance from the FDA on the proper use of social media.  With a flurry of guidances released this year, FDA has provided significant information for makers of prescription products who want to engage in social media channels that consumers and healthcare professionals are increasingly using to access healthcare information.

This session will provide an overview of the state of FDA guidance on social media with an emphasis on explaining where FDA has provided guidance on compliant use of social media and where FDA has failed to provide guidance.  Additionally, this session will discuss how you can implement and manage programs to mitigate compliance and brand risk.

Join our interactive online training course where you will learn:

  • The current state of FDA guidance on social media
  • Timing and next steps from FDA
  • Settled areas of FDA guidance that are unlikely to change
  • Controversial FDA positions that are likely to be revised
  • Key issues of remaining uncertainty
  • Risks vs. Benefits: “Selling” management on the importance of social media
  • Managing your social media activities to protect your brand
  • What’s worked, what hasn’t, and what’s happened as a result

This course will benefit senior decision makers who are determining whether to “green light” social media initiatives, marketers of prescription products who are trying to use social media, and regulatory professionals who are tasked with ensuring compliance of social media promotional tactics.

Dale Cooke is owner of PhillyCooke Consulting, which provides advice and training to companies about developing compliant promotional materials for FDA-regulated products. Dale has worked with more than 30 pharmaceutical and medical device clients around the world. His insights have been featured in the Wall Street Journal’s Health blog, The Pink Sheet, MedAdNews, PharmExec, and others. Dale is an active member of the Regulatory Affairs Professionals Society (RAPS), Drug Information Association (DIA), Food and Drug Law Institute (FDLI), and the Alliance for a Stronger FDA.  He also serves on the faculty of the University of California San Francisco’s American Course in Drug Development and Regulatory Sciences program.

Dale is the author of Effective Review and Approval of Digital Promotional Tactics, which is part of the FDLI’s primer series. He is regularly invited to speak at industry conferences on topics including FDA enforcement trends, best practices for review processes, global review practices, and life sciences use of social media. Previously, Dale served as the head of Regulatory for Digitas Health LifeBrands, which is part of the Publicis Healthcare Communications Group.

Dale earned his B.A. in Philosophy from Southern Methodist University and an M.A. in Analytical Philosophy from the University of Arizona and studied Epidemiology and Biostatistics at Drexel University’s School of Public Health and Healthcare Compliance at Seton Hall University’s School of Law.