Workshop - Social Media and Regulatory Constraints for Pharma in Europe and US - Martin Dubuc & Felix Jackson

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Transcript

  • 1. Regulatory environment in Pharma Felix Jackson Chief Medical Officer medDigital Martin Dubuc Head of Merck&Co Global MultiChannel Marketing
  • 2. Topics we will cover today
  • 3. Why am I here ? Felix Jackson – Chief Medical Officer medDigital• ABPI Medic, specialized into digital in 2008.• Worked on multiple, global or regional, digital initiatives• Expert in Codes and Regulations and how to apply them to digital.I hope to help you do that today!
  • 4. “Do you want to participate in a• Picture / Fun image Regulatory workshop ?”
  • 5. Why am I here ? Martin Dubuc – Head of Merck&Co MultiChannel MarketingLed digital and multichannel marketing activities /teams in: – France – Europe/Canada – Global/Regional & US marketOffer “insider” perspective and some “tips”, not anexpert of regulatory - nor a session on stating theobvious…Have an interactive dialog
  • 6. Topics we will cover today
  • 7. Let’s engageInteractive workshop … • What are the biggest challenges on digital marketing coming from regulations ? & what does it result in ? • Good practices you want to share ? • Do you feel that this is linked to regulation ? Or to the way we apply regulation ?
  • 8. Is the problem the regulatory environment or how it’s applied in Pharma?
  • 9. Some practical advice…• Train • Bring 3rd party company in to “train” medical / legal / compliance • Show the limitations of current approaches for the customer experience and business as part of it.• Clear intents • Ensure you understand the regulatory framework, and very clearly position your activities against it. Example : commercial / non commercial activities• Template / separate layout approval from content/brand approval • Build a cookbook for each digital channel, include a clear templating strategy that will be signed off by your medleg as the “way of doing”.
  • 10. Separate content approval fromlayout approval throught templating • Put clear SoPs, design templates and cookbooks in place for each of your digital Touchpoints. • Will both ease regulatory reviews but also improve customer experience / channel excellence
  • 11. Some remaining open questions …• In a digital world, content personalization on demand is critical but highly challenging to “validate” within certain markets...• In a world of “efficiency” most pharma are looking at promotion materials volume decrease as an objective. Nevertheless, the number of channels and complexity of campaigns tends to create opposite scenario.
  • 12. DISCUSSION
  • 13. Consider• Understand digital and how it is different• Clarify intent, promo/non-promo• Approval is complex: – Separate content from website structure – Interactive materials need to be described or viewed – Metadata – OS/Device considerations, eg screen size
  • 14. Topics we will cover today
  • 15. Is social really a media?...• Listen (&monitor) / Learn / Engage• Social capabilities for digital activities • Share • Contribute/Comment• HCP Social communities • Sermo, etc.• HCC • Facebook, twitter, etc.
  • 16. HCP world• Most Social players offer clear “products” for pharma which are more are less easy to bring through MedLeg • Data analysis / monitoring – Market research – Panels – “Posts / Threads” – etc.• Social on your own digital properties is usually “feasible” with limitations depending on local regulations: • Share on FB, twitter etc. (remove branded info.) • Pre approval of comments / posts • Peer to peer recommendation
  • 17. HCC world• SoP & “Social Media Council” is a must have …• Rules applies to all sites having social capabilities (iTunes store etc.)• Brand & Conversation monitoring !• exUS broader strategic question on patient strategy, social media are to be considered in this context• A rapidly changing environment… difficult for pharma to have a true “value proposition” at large scale
  • 18. DISCUSSION
  • 19. Consider• User-generated content and moderation policies• Responsibility and ownership• Adverse Event reporting responsibilities• Conflicting and unclear guidance• Social sharing metadata
  • 20. Topics we will cover today
  • 21. Operating across markets bring substantial complexity….• Significant variance in regulations impacting the content (for all channels)• Build your campaigns ready for adaptation and localization• Establish “modularity” in your content
  • 22. Operating in a global environment - Operation complexity varies depending on your set up : from source files to integrated shared digital serviceGLOBAL - Flexible design and flexible capabilities are critical Adaptation LocalizationLOCAL
  • 23. DISCUSSION
  • 24. Consider• Even more complex approval!• Approve once to one Code globally.• Structure of your central vs local teams.• Dedicated resource from medical, legal, safety, IT.• In-sourced services vs cutting-edge tech.
  • 25. WRAP UP& THANK YOU !