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Regulatory environment in         Pharma                    Felix Jackson           Chief Medical Officer medDigital      ...
Topics we will cover today
Why am I here ?      Felix Jackson – Chief Medical Officer medDigital• ABPI Medic, specialized into digital in 2008.• Work...
“Do you want to participate in a• Picture / Fun image   Regulatory workshop ?”
Why am I here ?     Martin Dubuc – Head of Merck&Co MultiChannel MarketingLed digital and multichannel marketing activitie...
Topics we will cover today
Let’s engageInteractive workshop …        • What are the biggest          challenges on digital          marketing coming ...
Is the problem the regulatory environment or how it’s                 applied in Pharma?
Some practical advice…• Train      • Bring 3rd party company in to “train” medical / legal / compliance      • Show the li...
Separate content approval fromlayout approval throught templating • Put clear SoPs, design templates and cookbooks in plac...
Some remaining open questions …• In a digital world, content personalization on  demand is critical but highly challenging...
DISCUSSION
Consider• Understand digital and how it is different• Clarify intent, promo/non-promo• Approval is complex:  – Separate co...
Topics we will cover today
Is social really a media?...• Listen (&monitor) / Learn / Engage• Social capabilities for digital activities      • Share ...
HCP world• Most Social players offer clear “products” for  pharma which are more are less easy to bring  through MedLeg   ...
HCC world• SoP & “Social Media Council” is a must have …• Rules applies to all sites having social capabilities  (iTunes s...
DISCUSSION
Consider• User-generated content and moderation  policies• Responsibility and ownership• Adverse Event reporting responsib...
Topics we will cover today
Operating across markets bring substantial                 complexity….• Significant variance in regulations impacting  th...
Operating in a global environment                    - Operation complexity varies depending on your set                  ...
DISCUSSION
Consider• Even more complex approval!• Approve once to one Code globally.• Structure of your central vs local teams.• Dedi...
WRAP UP& THANK YOU !
Workshop - Social Media and Regulatory Constraints for Pharma in Europe and US - Martin Dubuc & Felix Jackson
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Workshop - Social Media and Regulatory Constraints for Pharma in Europe and US - Martin Dubuc & Felix Jackson

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

  1. 1. Regulatory environment in Pharma Felix Jackson Chief Medical Officer medDigital Martin Dubuc Head of Merck&Co Global MultiChannel Marketing
  2. 2. Topics we will cover today
  3. 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. 4. “Do you want to participate in a• Picture / Fun image Regulatory workshop ?”
  5. 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. 6. Topics we will cover today
  7. 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. 8. Is the problem the regulatory environment or how it’s applied in Pharma?
  9. 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. 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. 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. 12. DISCUSSION
  13. 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. 14. Topics we will cover today
  15. 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. 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. 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. 18. DISCUSSION
  19. 19. Consider• User-generated content and moderation policies• Responsibility and ownership• Adverse Event reporting responsibilities• Conflicting and unclear guidance• Social sharing metadata
  20. 20. Topics we will cover today
  21. 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. 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. 23. DISCUSSION
  24. 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. 25. WRAP UP& THANK YOU !

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