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 theobviousHave an interactive dialog

6. Topics we will cover today

7. Lets 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 its 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 !