1. e in pharmacy Gatis Ozoliņš Head of Information Department State Agency of Medicines, Latvia Baltic IT&T 2005 Forum: eBaltics Rīga, 08 April 2005

2. 2 Pharmacy in numbers Registered medicinal products Latvia - ~4500 Each EU country from 3000 to 30 000 Market turnover in 2004 Latvia – 165 000 000 € EU – 130 000 000 000 € Gatis OzoliņšeBaltics 2005

3. 3 A little from history 1996 – IT systems are started to put into practice in governmental pharmaceutical sector in Latvia; 1998 – PHARE financed project for development of IT vision for pharmaceutical sector in Latvia; 2001 – the build of “first set” of IT systems has been completed.

4. 4 A circulation of information within EU EudraNET – secure network provider; EudraVigilance – system for monitoring adverse drug reactions; CTS – system for handling information regarding “mutual recognition medicines”; eSubmissions – system for exchange medicines registration information in electronic format; EudraCT – system for tracking clinical trials; … Gatis OzoliņšeBaltics 2005

5. 5 1st of May 2004 Legislation issues; Procedural issues in pharmaceutical market regulation; Need for information exchange between EU MS and EMEA; Various EU projects.

6. 6 Alignment with the EU information exchange Possibilities to harmonize IS within 25 countries and 45 regulatory bodies: TIG’es – Telematic Implementation Groups; Reference data models; Dictionaries. Gatis OzoliņšeBaltics 2005

7. 7 Structure of TIG’es Gatis OzoliņšeBaltics 2005 Pharmaceutical Committee TSC TMC TIG EudraNET TIG Eudra Vigilance TIG EuroPharm TIG EudraCT HoA

8. 8 Alignment with the EU information exchange Possibilities to harmonize IS within 25 countries and 45 regulatory bodies: TIG’es – Telematic Implementation Groups; Reference data models; Dictionaries. Gatis OzoliņšeBaltics 2005

9. 9 Milestones implemented EudraNET; CTS; EudraVigilance ; EudraCT. Gatis OzoliņšeBaltics 2005

10. 10 EudraNET Gatis OzoliņšeBaltics 2005

11. 11 milestones to go EuroPharm EudraGMP Dictionaries … Gatis OzoliņšeBaltics 2005

12. 12 Why should all before mentioned are needed? Why should we talk about eHealth and another e in pharmacy? Gatis OzoliņšeBaltics 2005

13. 13 EuroPHARM Main objective – Establishment of a common European database of information relating to all medicinal products on the market in the European Union. Gatis OzoliņšeBaltics 2005

14. 14 EuroPHARM – project goal A database of information about: all medicinal products authorized in the European Union; elements of the data held in the register of clinical trials; in all the official languages of the EU ; to all stakeholders in the system as appropriate; in a manner that ensures that the confidentiality of third party data held is maintained. Gatis OzoliņšeBaltics 2005

15. 15 EuroPHARM – project goal The database should enable access to related data from different sources by staff of competent authorities in the EU and all other stakeholders; minimise the physical input of information into national and pan-European systems; act as a reference source for other pan- European systems. Gatis OzoliņšeBaltics 2005

16. 16 Stakeholders Health Authorities within the European Union Competent Authorities in the European Union EMEA DG Enterprise DG SANCO Patients Health professionals Pharmaceutical industry WHO Council of Europe CEN Industry Associations Gatis OzoliņšeBaltics 2005

17. 1. A pharmaceutical industry has a product that needs to be (re-) evaluated and sends an eCTD containing an Electronic Application form and / or Product Information to one or more MS CAs. 2. The MS CA (s) receives, processes and stores the info in the file in its (their) national DB. EPh Outbox EPh Inbox EuroPharm QA Data Provider DB Validator Ack R Dictionaries Business Rules  Loader Log WWWWWWWW WWWWW WWWWW WWWWW EPh DA  WWWWWWWW WWWWW WWWWW WWWWW Ack A EPh Portal Flu 3. The national DB (s) generates overnight an XML file containing all new, modified or deleted product-related entries as approved at the end of the relevant national procedures and posts this file to the Inbox. 4. EuroPharm takes the file (s) from the Inbox. 5. The system sends an acknowledgement of receipt to the Data Provider. 6. The Validator validates the file (s) against the Dictionaries and Business Rules.7. The Validator concludes that the file (s) is valid.8. The Loader loads the file (s) into the EuroPharm Quarantine Area DB. A log file is created. 9. In the morning, the EuroPharm Data Administrator connects to the system and consults an overview of all activities since previous activities (loading of files from Data Providers, manual data entry and taking of files by the Authorised Bodies). 10. The EuroPharm DA approves all loaded files.11. The new information is published and made available for consultation via the EuroPharm Portal.12. The system sends an acknowledgement of formal acceptance of data in the DB to the Data Provider. 13. A user connects to the EuroPharm Portal. 14. The user selects his language 15. The user selects his profile. 16. The user launches the query module and enters his query criteria.17. The system executes the query. 18. The system displays the results from the query. 19. The user consults the query results. EPh DA Portal: Review & Acceptance Dictionary Data Entry

18. 18 Some more use cases Patients, together with their representative groups, seek better information on medicinal products constantly. Through the data repository held in the EuroPHARM database, and using a portal with access rights geared to the user, it is planned to provide access to data that is important to patients (indications; availability) on a search basis, the results being presented in a user friendly and uncluttered manner. Health professionals. It is expected that authoritative information may be made available through portal technology, to pharmacists and prescribers at the point of sale and prescription respectively. In addition, the database should enable immediate access for health professionals to the most up to date safety information relating to a product, accessible through the system and linked to the product name. Companies in the pharmaceutical sector will benefit as current, authoritative information relevant to their products will be available to all on an equal footing with their competitors. Companies will also benefit from the ability to submit data electronically. Gatis OzoliņšeBaltics 2005

19. 19 Where are we going with e? Danger OO + NT = EOO ???? Old Organisation New Technology $$$ Expensive Old Organisation Gatis OzoliņšeBaltics 2005

20. 20 Don’t forget Infrastructure Gatis OzoliņšeBaltics 2005

21. 21 Don’t forget Concerned partiesInfrastructure Gatis OzoliņšeBaltics 2005

22. 22 Don’t forget InfrastructureConcerned parties Gatis OzoliņšeBaltics 2005

23. 23 Don’t forget InfrastructureConcerned parties Gatis OzoliņšeBaltics 2005