PharmaCon2007 Conference Dubrovnik Croatia

1. EU Telematics Hans-Georg Wagner European Medicines Agency 05/26/09 Dubrovnik, Croatia, 22-27 May 2007

6. Centralised Authorisation Procedure - EMEA 05/26/09 Dubrovnik, Croatia, 22-27 May 2007 The EMEA is responsible for the evaluation and supervision of medicines for human and veterinary use in the European Union.

7. The Regulatory Life of a Medicinal Product 05/26/09 Dubrovnik, Croatia, 22-27 May 2007 CT Application CT Registration R&D Clinical Trials Application Evaluation Authorisation Post Marketing Scientific Advice Safety Monitoring AE Reporting NAP DCP/MRP CAP Application Safety Monitoring AE Reporting Risk Management Safety Monitoring AE Reporting Risk Management GMP

8. Matching IT Systems at EU Level 05/26/09 Dubrovnik, Croatia, 22-27 May 2007 CT Registration R&D Clinical Trials Application Evaluation Authorisation Post Marketing Scientific Advice Safety Monitoring AE Reporting CAP Application Safety Monitoring AE Reporting Risk Management GMP EudraCT EudraGMP EudraVigilance EudraVigilance E-Subm.

9. EudraVigilance (1) 05/26/09 Dubrovnik, Croatia, 22-27 May 2007 Adverse Event What happened? Which medicinal product? Which patient? Concomitant drugs? Active ingredients Route of Administration Pharmaceutical form

10. EudraVigilance (2) 05/26/09 Dubrovnik, Croatia, 22-27 May 2007 Adverse Event represent Agreed Data Model ‘ E2B’ Valid Values Valid Values Valid Values Dictionaries of controlled terms/codes ICSR SUSAR

12. EudraVigilance (4) 05/26/09 Dubrovnik, Croatia, 22-27 May 2007 Agreed Data Model ICSR HUMAN ICSR VET SUSAR HUMAN MedDRA EVMPD EV USERS EV CLIENT AXWAY EV WEB TRADER AXWAY CENTRAL GATEWAY DWH BI SE

13. EudraVigilance (5) 05/26/09 Dubrovnik, Croatia, 22-27 May 2007 Agreed Data Model EVPM EVCTM EVMPD Prod. SUSAR ICSR Gateway ETL BI MSTR STATS SAS Reports Reports Data Cleaning Duplicate Detection EVIDS

15. EudraCT (1) 05/26/09 Dubrovnik, Croatia, 22-27 May 2007 Protocol? Which Investigational MP? Sites? Sponsor? Active ingredients Route of Administration Pharmaceutical form Strength Clinical Trial Paediatric? Unique ID?

16. EudraCT (2) 05/26/09 Dubrovnik, Croatia, 22-27 May 2007 Sponsor National Competent Authority Ethics Committee EudraCT Public Site Collect EudraCT Number Download Application Form Submit Application EudraCT Secure Site EudraCT Application EudraCT Repository Register Clinical Trial

19. EudraPharm (1) 05/26/09 Dubrovnik, Croatia, 22-27 May 2007 Regulatory data (MAH, dates, procedure…) Excipients Names, Codes Active ingredients Route of Administration Pharmaceutical form Strength Presentations Medicinal Product Paediatric? Unique Product ID? LBL PIL SPC

20. EudraPharm (2) 05/26/09 Dubrovnik, Croatia, 22-27 May 2007 Structured Data Medicinal Product LBL PIL SPC Relational DB Text Repository Public Site Web Services

21. EudraPharm (3) 05/26/09 Dubrovnik, Croatia, 22-27 May 2007 CAP (400) 23+1L DCP MRP (4000) N+1L NAP (400000) 1(+1)L EudraPharm All products All languages

24. EudraGMP (1) 05/26/09 Dubrovnik, Croatia, 22-27 May 2007 Medicinal Product GMP Inspectorates Member States Inspection Certificate Manufacturing Sites 1:n GMP Inspection Manufacturing Authorisation GMP Inspectorates MRA States Inspection Certificate GMP Inspection Negative Outcome Product Alert EudraGMP Database

26. 05/26/09 Dubrovnik, Croatia, 22-27 May 2007 Eudra GMP Eudra CT Eudra Vig. Eudra pharm e Subm. Reference Data Model EU Telematics Controlled Terminology EudraDataWarehouse EudraServices EudraNet, EudraLink, Web Services, SSO EudraPortal

27. 05/26/09 Dubrovnik, Croatia, 22-27 May 2007 Hans-Georg Wagner EMEA Communications and Networking [email_address]