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.