e in pharmacy gatis ozoliņš head of information department state agency of medicines, latvia...

e in pharmacye in pharmacyGatis Ozoliņš

Head of Information DepartmentState Agency of Medicines,

Latvia

Baltic IT&T 2005 Forum: eBalticsBaltic IT&T 2005 Forum: eBaltics

RīgaRīga, , 08 April 08 April 20020055

2

Pharmacy in numbersPharmacy in numbers

Registered medicinal productsLatvia - ~4500Each EU country from 3000 to 30 000

Market turnover in 2004Latvia – 165 000 000 €EU – 130 000 000 000 €

Gatis OzoliņšGatis Ozoliņš eBaltics 2005eBaltics 2005

3


A little from historyA 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

A circulation of information within EUA 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;…


5


1st of May 20041st of May 2004

Legislation issues;Procedural issues in pharmaceutical

market regulation; Need for information exchange between

EU MS and EMEA;Various EU projects.

6

Alignment with the EU information exchangeAlignment 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.


7

Structure of TIG’esStructure of TIG’es


Pharmaceutical Committee

TSC

TMC

TIGEudraNET

TIGEudra

Vigilance

TIGEuroPharm

TIGEudraCT

HoA

8

Alignment with the EU information exchangeAlignment 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 Ozolins

Šis slaids ir jāpapildinaTIGu shēma vēl varbūt ir jāparāda.Kaut kas ilustratīvs par RDM

9

Milestones implementedMilestones implemented

EudraNET;CTS;EudraVigilance ;EudraCT.


10

Germany

Internet Router

IPVPN

Latvia

Estonia

Eudranet services

Internet

Globix line

RouterRouter

MCI

Router

Router

IPVPN

IPVPN

Firewall Monitoring system

EudraTrack

SNMP

Other protocolos

EudraNETEudraNET


11

milestones to gomilestones to go

EuroPharmEudraGMPDictionaries…


12

Why should all before mentioned are Why should all before mentioned are needed? Why should we talk about needed? Why should we talk about

eHealth and another e in pharmacy?eHealth and another e in pharmacy?


13

EuroPHARM EuroPHARM

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


14

EuroPHARM – project goalEuroPHARM – 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.


15

EuroPHARMEuroPHARM – project goal – project goal

The database shouldenable 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.


16

StakeholdersStakeholders

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


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.

EPhOutbox<Rec>

EPhInbox

EuroPharm

QA

DataProvider

DB

Validator

Ack R

DictionariesBusiness Rules

LoaderLog

WWW WW WWW WWW

WWW WW WWW WWW

WWW WW WWW WWW

WWW WW WWW WWW

EPh DA

WWW WW WWW WWW

WWW WW WWW WWW

WWW WW WWW WWW

WWW WW WWW WWW

Ack A

EPhPortal

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 language15. 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 DAPortal:Review

&AcceptanceDictionary

DataEntry

18

Some more use casesSome 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.


19

Where are we going with e?Where are we going with e?DangerDanger

OO + NT = EOO ????

Old Organisation New Technology

$$$

ExpensiveOld

Organisation


20

Don’t forgetDon’t forget

Infrastructure


21


Concerned partiesInfrastructure


22


Infrastructure Concerned parties


23


Infrastructure Concerned parties


e in pharmacy gatis ozoliņš head of information department state agency of medicines, latvia...

Documents

eudranetgatis ozoliebaltics

gatis ozolins

handling information

circulation of information

eu country

physical input of information

european unionelements

paneuropean systems