Social Media Regulatory Affairs Summit

Social media … Is it a dream or nightmare?

Marketers dream of social media’s reach. Patients are using it — learning about their conditions — and talking to their doctors about what they’ve discovered.

But, it can become a regulatory nightmare for drug- and devicemakers if well-designed policies and procedures aren’t in place.

Many drug and device companies have a successful social media presence. How can you join them, reaping the sales and marketing benefits while satisfying the FDA at the same time?

You can make the dream come true — and learn much more — when you register to attend the FDAnews Social Media Regulatory Affairs Summit on June 24-25, 2015, at the National Press Club in Washington, DC.

A Faculty of Knowledgeable Experts on
Social Media for Drug- and Devicemakers

The conference co-chairmen are experts whose tremendous experience and differing perspectives will give you a unique take on the issues with using social media — and what you need to do to succeed with it.

Dale A. Cooke, the owner of PhillyCooke Consulting, specializes in helping FDA-regulated companies develop compliant promotional tactics and improve the promotional review. He is the author of Effective Review & Approval of Digital Promotional Tactics.

Peter Pitts is co-founder and president of Center for Medicine in the Public Interest. He was previously the FDA's associate commissioner for external relations, serving as the agency's "chief messaging officer," where his challenge was to define the FDA's brand image and to communicate its main themes to its varied constituencies.

Dale and Peter will be supported by an all-star cast of knowledgeable experts who will be prepared to share their in-the-trenches experiences in integrating social media into their companies' and clients' business plans.

To learn more and register.

What's In Store for You?
A Sampling of Speakers and Topics

Ten Social Pitfalls to Avoid
Marianne Slivcova, Senior Corporate Counsel at Bristol Myers Squibb, will explain, using real-life illustrations from industry, the risks to be considered in operating in the social media world.

Getting to Yes: The Path to Satisfying Both ROI and the FDA
Sean Nicholson from InTouch Solutions has helped dozens of drug and device companies go from frightened neophytes to social media rock stars. He'll cover key topics such as: What you need to ask when starting out with social media, what key metrics must you track, how to define social media success (and more).

Adverse Event Reporting and Social Media
When it comes to social media, adverse events reporting is one of the most challenging regulatory requirements to translate from real life to a virtual world. Anne Maher, from Kleinfield, Kaplan & Becker, will walk you through FDA requirements, plus provide real-world examples of adverse events that don’t neatly fit into the FDA’s scenarios — and how to deal with them.

Review the Full Agenda and Speakers.

A Thorough Coverage of Issues:
More of What You Will Learn

  • How to analyze the ROI of a social media effort
  • Success stories: How other companies conquered their fear of social media and made it pay
  • The future: What the FDA has in store for social media enforcement and guidance in the years ahead
  • How to comply with the rules for off-label promotion on social media
  • Twitter: How to present risk-benefit information in a character-limited world
  • When (and whether) you should correct misinformation about your product online
  • Industry Leaders Panel: The state of the industry and future of social media
  • And much more

Our guarantee to you: Be prepared for two exciting, fact-filled days of cutting edge commentary, case studies, expert analysis — and more — when you attend FDAnews' Social Media Regulatory Affairs Summit.

You'll find this event to be a rare opportunity to gain invaluable knowledge … by spending time with acknowledged experts … rubbing elbows with colleagues who have the same issues as you … picking their brains … absorbing their experiences … and developing contacts that'll be helpful to you all through the year.


Binder Materials:

  • Slides from PowerPoint presentations
  • Reference docs:
    • Internet/Social Media Platforms with Character Space Limitations — Presenting Risk and Benefit Information for Prescription Drugs and Medical Devices
    • Internet/Social Media Platforms: Correcting Independent Third-Party Misinformation About Prescription Drugs and Medical Devices
    • Fulfilling Regulatory Requirements for Postmarketing Submissions of Interactive Promotional Media for Prescription Human and Animal Drugs and Biologics
    • Responding to Unsolicited Requests for Off-Label Information About Prescription Drugs and Medical Devices