CDISC in Europe. CDISC Interchange Japan, Tokyo, July 20, 2010

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1 CDISC in Europe Pierre-Yves Lastic, PhD Chairman, CDISC E3C & French User Group Senior Director, Data Privacy & Healthcare Interoperability Standards, Sanofi-Aventis R&D CDISC Interchange Japan, Tokyo, July 20, 2010

2 Healthcare in Europe heterogeneous, complex and growing fast 27 member countries and growing 23 languages 500 million people 330 practicing doctors per 100,000 inhabitants 640 hospital beds per 100,000 inhabitants Source: 2

3 GP Number for 100,000 inhabitants 3

4 Electronic exchange of healthcare data for at least one purpose 4

5 Purpose of electronic exchange (selected countries) 5

6 Priorities in National Health Strategies 6

7 CDISC and ehealth The synergy between the Health and ICT sectors brings great value to individual patients, health delivery systems and the economy (Viviane Reding, EU Commissioner Information Society and Media) 2009 European Health Market Sizes Traditional: Pharmaceuticals: 205 Billions Euros (> $300 Billions) Medical Devices: 64 Billions Euros (> $90 Billions) New: ehealth: 60 Billions Euros (~ $90 Billions) > Already positionned as a key enablers in bringing drugs and devices faster to the market, CDISC standards are also a key component of the new ehealth sector 7

8 European CDISC Coordinating Committee (E3C) Think globally act locally Development of standards by global committees Promotion of standards on a regional basis Support global CDISC initiatives within Europe Provide regional feedback to the central organisation Provide guidance on EU-specific issues Act as liaison between EU organisations and CDISC 10 members for a maximum of two terms of three years Representatives from at least UK, Germany and France CDISC President and VP of Education are also members Ex-officio position for European Board of Directors members 8

9 Key initiatives in Europe Think globally act locally Awareness and Training Annual European CDISC Interchange CDISC Roadshows Support European User Groups Key stakeholder dialogue Collaboration with European Medicines Agency (EMA) Collaboration with European Federation of Pharmaceuticals Industries and Associations (EFPIA) and European Commission on Electronic Health Record use for clinical research and pharmacovigilance within the Innovative Medicine Initiative (IMI) and the EFPIA ehealth Task Force Engage with national ISO committees Liaise with HL7 Europe and European HL7 Affiliates Colead global CDISC projects CDISC SHARE 9

10 European CDISC Interchange in London April Standards in the city Royal Lancaster Hotel Hyde Park, London 10

11 European Interchange 2010 vs Conference Attendees Budapest London => +20% Training + Conference Budapest London => + 30% 11

12 European Interchange Innovations Break-Out Sessions More Interactivity for Participants Better Feedback for CDISC Posters More space to share experience Other ideas => Contact us! Amanda de Montjoie ( ademontjoie@cdisc.org ) Pierre-Yves Lastic ( pierre-yves.lastic@sanofi-aventis.com ) 12

13 CDISC Roadshows An event near you Provide CDISC introduction and overview in one day Technical overview, model updates, implementation studies Staffed with European experts So far > 350 participants in six events Last events Dublin, Ireland (Nov 08) Sofia, Bulgaria (Feb 09) Riga, Lettland (Sept 09) To be continued... 13

14 European CDISC Usergroups Building a pan-european knowledge base English-speaking German-speaking French-speaking Italian-speaking Nordic Coordinated at the EU-level Tied into the CDISC Global User Network E3C supports foundation, individual groups work independently By the user, for the user 14

15 European Medicines Agency (EMA) CDISC participates in the Joint Operations Group of the EMA Telematics Implementation Group Contributes together with HL7 in creating and maintaining standards for Clinical Trials Protocols (EudraCT Database) Adverse Events Reporting (EudraVigilance) Drug Terminology (EudraPharm) CDISC published the esdi document that is the basis for the new EU Guidance on Electronic Source Documents used in Clinical Trials 15

16 Innovative Medicine Initiative (IMI) 16

17 Strength through collaboration. 17