1. Information Technology at EMEA Current activities and the Way Ahead Presentation to the Workshop on Future of Telematics in Pharmaceuticals 20 April 2001 by Thomas Lönngren, Executive Director, EMEA

2. EMEA IT Activities l EMEA IT u Running internal IT system u Develop new internal systems u Develop EudraVigilance u PIM (Product information management) l ETOMEP u Support by JRC u Web site and EudraNet

3. EMEA IT systems in operation l General office PC network and e-mail system l Operational systems u EMEA public catalogue documentation system u Third country export certificates database u European experts database u ‘Scientific memory’ database u ‘Scientific advice’ database l Administrative and support systems u ActiTrak (time-cost analysis for analytical accounting) u Financial software system u Revenue and expenditure database u Personnel database

4. CostMan estimatemonths EudraVigilance€ 550,00012 Project Information Management (internal resources) 6 Personnel database€ 270,00012 Document management system€ 1,546,0006 SIAMED tracking system€ 320,00012 Meeting management system (internal resources) 6 IT systems under development

5. Other projects and further developments: Man months Electronic submission6 Orphan drug database2 Desktop videoconferencing facilities6 GMP inspections database2 Scientific advice and scientific memory databases5 European experts database3 Other projects2 Total = 80 man months (or 8 people) IT systems under development

6. IT financial and human resources

7. The EU IT situation l The 3 regulatory partners are u EMEA u European Commission JRC DG Enterprise IDA u Member States Heads of Agencies and the MRFG/VMRFG l Overall management by Telematics Steering Committee (chaired by Commission)

8. The questions? l What kind of systems are needed for the European authorisation system? l Who is responsible for developing, running and maintaining these systems? l Who will finance these systems? l The new management structure set up by the European Commission has to answer these questions (strategy currently under preparation)

9. The role of EMEA l Short term u EMEA focus on internal needs and EudraVigilance (in the 2002 budget) u Maintain present cooperation with JRC l Long term u Depends on the coming strategy u EMEA input to this strategy: take EU responsibility for development, running, maintaining and financing IT systems? only responsible for IT under the centralised system?