1. How to successfully Implement and Leverage the Regulatory Intelligence Function Marianne Koehne EU RI Network Group; Global RI Manager Boehringer Ingelheim 26th Annual EuroMeeting 25-27 March 2014 ACV, Vienna Austria

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3. EU Regulatory Intelligence Network Group (EU RING) The purpose of the EU Regulatory Intelligence Network Group (EU RING) is to raise pharmaceutical regulatory intelligence professionals’ expertise by sharing organisation, working practices, and experience in non- confidential areas of work. The EU RING provides an informal forum for regulatory intelligence specialists serving the pharmaceutical and biopharmaceutical sector 3

4. Overview RI - Definition and Drivers RI functions in the EU RING group RI responsibilities Challenges and conditions for success Demonstrating the value of the RI function Measuring the value of RI deliverables Key messages and conclusions 4

5. What is Regulatory Intelligence? Regulatory intelligence (RI) is of processing targeted publicly available information and data from multiple sources, analysing the data in its relevant context and generating a "meaningful" output - eg outlining risks and opportunities - to a regulatory strategy. The process is driven by business needs and linked to decisions and actions in daily business. 5

6. What about Regulatory Policy? Regulatory Policy mostly refers to the company external position. Together with the Regulatory Intelligence it influences companies’ regulatory strategies in accordance with the company position vice versa. 6

7. Regulatory Intelligence Drivers (1) Pharmaceutical business is acting in a highly regulated and constantly changing environment,  regulatory intelligence obviously a permanent responsibility for experts in all disciplines and units of a pharmaceutical company, in particular for all RA managers. It covers GxP scientific disciplines as well. 7

8. Regulatory Intelligence Drivers (2) However, certain aspects of regulatory intelligence activities beyond the scope of the individual product/project and with relevance to several disciplines are attributed to / coordinated by the regulatory intelligence unit. In bigger pharmaceutical companies product / project related regulatory intelligence might be assigned to the RI unit, also watching disease area specific development requirements. 8

9. RI function in the EU RING Group (1) The number of RI professionals in EU RING companies varies broadly, despite the fact that 11/13 companies have > 10.000 employees: 7/13 companies have less than 5 staff members, 3/13 more than 10 in 7/13 companies the RI function exists > 10 years, in 5/13 companies between 5 and 10 years in addition to EU and North America, 8/13 companies have nominated RI network partners in Asia Pacific, 5/13 in Latin America as well 9

10. RI function in the EU RING Group (2) Reporting lines of Regulatory Intelligence are directly to Head of Global RA in 2/13 companies, 6/13 companies have one more level in between, in 2/13 companies the RI function is 4 organisational levels away RI and Regulatory Policy work closely together, but In global companies reporting lines may be different in the EU and US 10

11. RI Responsibilities (1) Core RI responsibilities Data mining, selection, analysis and targeted dissemination of regulatory information Tracking of legislative processes for upcoming regulations and enforcement Management of company internal processes around draft / final guidelines incl. impact assessments (some companies) Company internal consultancy around regulatory information, availability and interpretation of documents Knowledge source for regulatory advice on request 11

12. RI Responsibilities (2) Optional scope, mostly in larger RI units, e.g. reports on regulatory trends to senior and executive management broader dissemination of regulatory news to non-RA staff management of RA related internal websites, databases, electronic information and distribution systems regulatory competitive information 12

13. Challenges and Conditions for Success Global Integration of information – have a process or company forum in place for sharing information across regions Define the targeted audience realistically Decide, which areas will be covered / not covered systematically; Communicate!! Efficient news service understanding customers needs Safeguard flow of business critical information centrally even if information is country specific 13

14. Demonstrating the value of RI (1) 14 The regulatory intelligence function MUST be visible, recognised and supported by management to add value to the business,e.g. via Periodical summaries of RI contributions to be submitted / presented to senior managment RI being consulted systematically during the drafting of product development plans Timely information and educational meetings

15. Demonstrating the value of RI (2) 15 DeliverableMetrics of Success (examples only) Managing consultation on draft guidelines Number of comments incorporated in draft guideline etc. Deployment of final guidelines and company internal impact assessments Number of impact assessments Number of process changes identified Number of internal SOPs changed etc.

16. Demonstrating the value of RI (3) 16 DeliverableMetrics of Success (examples only) Input into regulatory strategies Number of times RI is asked before decision making time saved by reg. strategists Internal presentations / training Increase compliance Reduce time spent by individuals on learning new requirements

17. Demonstrating the value of RI (4) 17 DeliverableMetrics of Success (examples only) Management support / briefing issues: support of regulatory strategies Number of time management decision are influenced Number of time RI is invited actively for briefings Creation of newsletters, bulletins, alerts (incl. company internal impact assessments as appropriate) Number of times actions have been influenced immediately Number of readers Ad hoc queriesNumber of times decisions are altered/influenced

18. Measuring the value of RI deliverables (1) DeliverableReduce costs Saves time Ensures compliance Increases chance of reg.success quant qual Managing consultation on draft guidelines x x x x Deployment of final GL‘s an company internal impact assessments x x 18

19. Measuring the value of RI deliverables (2) DeliverableReduce costs Saves time Ensures compliance Increases chance of reg.success quant qual Input into regulatory strategies xx x Internal presentations / training xx xx Management support / briefing issues x x x 19

20. Measuring the value of RI deliverables (3) DeliverableReduce costs Saves time Ensures compliance Increases chance of reg.success quant qual Creation of newsletters, bulletins, alerts xx x Ad hoc queries xxxx 20

21. EU RING Communication 21 Publications (selected) EU RING members, “The Company Regulatory Intelligence (RI) Function” RAJ Pharma Oct 2007, p671-673: EU RING members, „Sharing regulatory intelligence: Are newsletters here to stay or is social media the future?“ Regulatory Rapporteur – TOPRA, 8(5), May 2011, p5-8 Under preparation: EU RING members „Measuring the value of the regulatory intelligence function“ LinkedIn Group Forum for regulatory affairs professionals interested in following the activities of the EU RING and sharing best practices/articles related to regulatory intelligence activities in the biopharmaceutical area

22. Key Messages and Conclusions(1) 22 Core task of a Regulatory Intelligence function is to create awareness, provide strategic impact analysis and support knowledge flow in the rapidly moving and changing regulatory environment set up of a well defined and resources RI unit save company resources – do it once provide targeted input into development and life cycle management projects optimise communication of RI Know the customer – and think about added value

23. Key Messages and Conclusions(2) 23 Watch the global regulatory environment – According to business needs nothing is granted! Find the right mixture of theory (regulatory texts) and practical experiences (application / interpretation)

24. 24 This presentation was given on behalf and with support of the EU RING. Special acknowledgements to Iain Todd, GSK, EU RING co-chair, for the part on added value of RI THANK YOU FOR YOUR ATTENTION