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e in pharmacy

e in pharmacy. Gatis Ozoliņš Head of Information Department State Agency of Medicines, Latvia. Baltic IT&T 2005 Forum: eBaltics Rīga , 08 April 200 5. Pharmacy in numbers. Registered medicinal products La t via - ~4500 Each EU country from 3000 to 30 000 Market turnover in 2004

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e in pharmacy

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  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. 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 Ozoliņš eBaltics 2005

  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. Gatis Ozoliņš eBaltics 2005

  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 Ozoliņš eBaltics 2005

  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. Gatis Ozoliņš eBaltics 2005

  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 Ozoliņš eBaltics 2005

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

  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 Ozoliņš eBaltics 2005

  9. Milestones implemented • EudraNET; • CTS; • EudraVigilance ; • EudraCT. Gatis Ozoliņš eBaltics 2005

  10. EudraNET Gatis Ozoliņš eBaltics 2005

  11. milestones to go • EuroPharm • EudraGMP • Dictionaries • … Gatis Ozoliņš eBaltics 2005

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

  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 Ozoliņš eBaltics 2005

  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 Ozoliņš eBaltics 2005

  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 Ozoliņš eBaltics 2005

  16. 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 Stakeholders Gatis Ozoliņš eBaltics 2005

  17. EPh DA Business Rules EPh Portal Loader EPh Inbox Log Flu EuroPharm Validator Data Provider DB  QA EPh DA Portal: EPh Outbox <Rec>  Review & Acceptance Ack R Dictionaries Ack A Dictionary Data Entry 2. The MS CA (s) receives, processes and stores the info in the file in its (their) national DB. 18. The system displays the results from the query. 19. The user consults the query results. 17. The system executes the query. 16. The user launches the query module and enters his query criteria. 13. A user connects to the EuroPharm Portal. 14. The user selects his language 15. The user selects his profile. 12. The system sends an acknowledgement of formal acceptance of data in the DB to the Data Provider. 11. The new information is published and made available for consultation via the EuroPharm Portal. 10. The EuroPharm DA approves all loaded files. 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). 8. The Loader loads the file (s) into the EuroPharm Quarantine Area DB . A log file is created. 7. The Validator concludes that the file (s) is valid. 6. The Validator validates the file (s) against the Dictionaries and Business Rules. 4. EuroPharm takes the file (s) from the Inbox. 5. The system sends an acknowledgement of receipt to the Data Provider. 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. 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.

  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 Ozoliņš eBaltics 2005

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

  20. Don’t forget Infrastructure Gatis Ozoliņš eBaltics 2005

  21. Don’t forget Infrastructure Concerned parties Gatis Ozoliņš eBaltics 2005

  22. Don’t forget Infrastructure Concerned parties Gatis Ozoliņš eBaltics 2005

  23. Don’t forget Infrastructure Concerned parties Gatis Ozoliņš eBaltics 2005

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