EU Telematics Hans-Georg Wagner European Medicines Agency 05/26/09 Dubrovnik, Croatia, 22-27 May 2007
Objectives <ul><li>What is EU Telematics? </li></ul><ul><li>Why do we need it? </li></ul>05/26/09 Dubrovnik, Croatia, 22-2...
Overview <ul><li>Introduction </li></ul><ul><li>Regulation of medicinal products in the EU/EEA </li></ul><ul><li>The regul...
Introduction <ul><li>IT polarises: necessary evil? </li></ul><ul><li>Today’s regulatory workflows cannot work without IT! ...
Authorisation of Pharmaceuticals in the EU 05/26/09 Dubrovnik, Croatia, 22-27 May 2007  <ul><li>Biotech </li></ul><ul><li>...
Centralised Authorisation Procedure - EMEA 05/26/09 Dubrovnik, Croatia, 22-27 May 2007  The EMEA is responsible for the ev...
The Regulatory Life of a Medicinal Product 05/26/09 Dubrovnik, Croatia, 22-27 May 2007  CT Application CT  Registration R&...
Matching IT Systems at EU Level 05/26/09 Dubrovnik, Croatia, 22-27 May 2007  CT  Registration R&D Clinical Trials Applicat...
EudraVigilance (1) 05/26/09 Dubrovnik, Croatia, 22-27 May 2007  Adverse Event What happened? Which medicinal  product? Whi...
EudraVigilance (2) 05/26/09 Dubrovnik, Croatia, 22-27 May 2007  Adverse Event represent Agreed Data Model ‘ E2B’ Valid Val...
EudraVigilance (3) <ul><li>Why at EU-level? </li></ul><ul><li>Signal detection is based on relative frequency of adverse e...
EudraVigilance (4) 05/26/09 Dubrovnik, Croatia, 22-27 May 2007  Agreed Data Model ICSR HUMAN ICSR VET SUSAR HUMAN MedDRA E...
EudraVigilance (5) 05/26/09 Dubrovnik, Croatia, 22-27 May 2007  Agreed Data Model EVPM EVCTM EVMPD Prod. SUSAR ICSR Gatewa...
EudraVigilance - Issues <ul><li>Need to include products from outside EU </li></ul><ul><li>Need to implement controlled te...
EudraCT (1) 05/26/09 Dubrovnik, Croatia, 22-27 May 2007  Protocol? Which  Investigational MP? Sites? Sponsor? Active ingre...
EudraCT (2) 05/26/09 Dubrovnik, Croatia, 22-27 May 2007  Sponsor National Competent  Authority Ethics Committee EudraCT Pu...
EudraCT (3) <ul><li>Why at EU-level? </li></ul><ul><li>Avoid duplication </li></ul><ul><li>Share safety concerns </li></ul...
EudraCT - Issues <ul><li>Need to link to EudraVigilance </li></ul><ul><li>Need to know more about new product </li></ul><u...
EudraPharm (1) 05/26/09 Dubrovnik, Croatia, 22-27 May 2007  Regulatory data (MAH, dates, procedure…) Excipients Names, Cod...
EudraPharm (2) 05/26/09 Dubrovnik, Croatia, 22-27 May 2007  Structured Data Medicinal Product LBL PIL SPC Relational DB Te...
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 EudraP...
EudraPharm (4) <ul><li>Why at EU-level? </li></ul><ul><li>Safety monitoring </li></ul><ul><li>Information sharing </li></u...
EudraPharm - Issues <ul><li>Need reference data model </li></ul><ul><li>Need controlled terminology </li></ul><ul><li>Need...
EudraGMP (1) 05/26/09 Dubrovnik, Croatia, 22-27 May 2007  Medicinal Product GMP Inspectorates Member States Inspection Cer...
EudraGMP (2) <ul><li>Why at EU-level? </li></ul><ul><li>Avoid duplication, share effort </li></ul><ul><li>Extend to MRA pa...
05/26/09 Dubrovnik, Croatia, 22-27 May 2007  Eudra GMP Eudra CT Eudra Vig. Eudra pharm e Subm. Reference Data Model EU Tel...
05/26/09 Dubrovnik, Croatia, 22-27 May 2007  Hans-Georg Wagner EMEA Communications and Networking [email_address]
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EU telematics in the regulation of pharmaceuticals

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EU telematics in the regulation of pharmaceuticals

  1. 1. EU Telematics Hans-Georg Wagner European Medicines Agency 05/26/09 Dubrovnik, Croatia, 22-27 May 2007
  2. 2. Objectives <ul><li>What is EU Telematics? </li></ul><ul><li>Why do we need it? </li></ul>05/26/09 Dubrovnik, Croatia, 22-27 May 2007
  3. 3. Overview <ul><li>Introduction </li></ul><ul><li>Regulation of medicinal products in the EU/EEA </li></ul><ul><li>The regulatory life of a medicinal product </li></ul><ul><li>Matching IT systems </li></ul>05/26/09 Dubrovnik, Croatia, 22-27 May 2007
  4. 4. Introduction <ul><li>IT polarises: necessary evil? </li></ul><ul><li>Today’s regulatory workflows cannot work without IT! </li></ul><ul><li>Look at regulation of pharmaceuticals in EU </li></ul><ul><li>Then derive need for IT systems </li></ul>05/26/09 Dubrovnik, Croatia, 22-27 May 2007
  5. 5. Authorisation of Pharmaceuticals in the EU 05/26/09 Dubrovnik, Croatia, 22-27 May 2007 <ul><li>Biotech </li></ul><ul><li>4 Therapeutic Classes </li></ul><ul><li>All others </li></ul>MUST CAN Centralised AP DCP MRP NAP
  6. 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. 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. 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. 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. 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
  11. 11. EudraVigilance (3) <ul><li>Why at EU-level? </li></ul><ul><li>Signal detection is based on relative frequency of adverse events </li></ul><ul><li>Earlier detection of potential signals </li></ul><ul><li>Higher degree of confidence in signal </li></ul>05/26/09 Dubrovnik, Croatia, 22-27 May 2007 ‘ E2B’
  12. 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. 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
  14. 14. EudraVigilance - Issues <ul><li>Need to include products from outside EU </li></ul><ul><li>Need to implement controlled terms for </li></ul><ul><ul><li>Substances (active and excipients) </li></ul></ul><ul><ul><li>Pharmaceutical form </li></ul></ul><ul><ul><li>Route of administration </li></ul></ul><ul><ul><li>Strength units </li></ul></ul><ul><li>Quality of source data </li></ul><ul><li>Duplicate detection, recoding product data, validation </li></ul><ul><li>Manage access policies for different stakeholders </li></ul>05/26/09 Dubrovnik, Croatia, 22-27 May 2007 ‘ E2B’
  15. 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. 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
  17. 17. EudraCT (3) <ul><li>Why at EU-level? </li></ul><ul><li>Avoid duplication </li></ul><ul><li>Share safety concerns </li></ul><ul><li>Large percentage of multi-state trials </li></ul>05/26/09 Dubrovnik, Croatia, 22-27 May 2007 ‘ E2B’
  18. 18. EudraCT - Issues <ul><li>Need to link to EudraVigilance </li></ul><ul><li>Need to know more about new product </li></ul><ul><li>Need to include information on paediatric trials </li></ul><ul><li>Data quality issues </li></ul><ul><li>Usability issues (especially for NCAs) </li></ul><ul><li>Manage access policies for different stakeholders </li></ul>05/26/09 Dubrovnik, Croatia, 22-27 May 2007 ‘ E2B’
  19. 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. 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. 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
  22. 22. EudraPharm (4) <ul><li>Why at EU-level? </li></ul><ul><li>Safety monitoring </li></ul><ul><li>Information sharing </li></ul><ul><li>Decision support </li></ul><ul><li>Mobility (Patients, Health Professionals,…) </li></ul>05/26/09 Dubrovnik, Croatia, 22-27 May 2007 ‘ E2B’
  23. 23. EudraPharm - Issues <ul><li>Need reference data model </li></ul><ul><li>Need controlled terminology </li></ul><ul><li>Need exchange standard </li></ul><ul><li>NCAs should provide data (NAP+DCP/MRP) </li></ul><ul><li>Data providers need to ensure quality and timeliness </li></ul><ul><li>Role of industry? </li></ul><ul><li>Links to other systems </li></ul><ul><li>Manage access policies for different stakeholders </li></ul>05/26/09 Dubrovnik, Croatia, 22-27 May 2007 ‘ E2B’
  24. 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
  25. 25. EudraGMP (2) <ul><li>Why at EU-level? </li></ul><ul><li>Avoid duplication, share effort </li></ul><ul><li>Extend to MRA partners outside EU/EEA </li></ul><ul><li>Mitigate risks (negative outcome) </li></ul><ul><li>Rapid product alert </li></ul>05/26/09 Dubrovnik, Croatia, 22-27 May 2007 ‘ E2B’
  26. 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. 27. 05/26/09 Dubrovnik, Croatia, 22-27 May 2007 Hans-Georg Wagner EMEA Communications and Networking [email_address]

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