Eudranet

Esteban Gonzalez- Juarros,
Project Officer d’EudraNet

"EudraNet va renforce son rôle de portail de communication sécurisée entre les agences et les firmes pharmaceutiques."

by Corinne RADAL

19 february 2001
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Did you meet obstacles in the implementation of EudraNet ?

EudraNet is a platform that facilitates the operation of existing procedures and enables completely new processes. The following points represent critical factors that have contributed to the successful implementation of EudraNet :

• The technical excellence of the JRC project manager that made possible a high quality service enabling the reliable paper-less operation of regulatory procedures;
• The dedication by national Information Officers, represented at the EudraNet Working Group, that made possible the integration of local sites into a European collaborative environment and that maintain the policies and operational procedures that govern the network;
• The commitment by the management of the Commission, the EMEA and the National Authorities to introduce new tools and work-methods into existing regulatory practices;
• The open mind by regulators and industry to agree on operational objectives with the view of improving the overall efficiency of the regulatory system.

What is your role in the project ?

EudraNet is the result of a collaborative effort that comprises financial, organisational, legal and technical aspects and that requires the co-operation of DG Enterprise, the Joint Research Centre, the IDA Programme, the national regulatory authorities and the pharmaceutical industry.

As project leader, I have been responsible for planning and co-ordination of multiple contributions, contributions that have made possible that EudraNet becomes the first secure and managed telecommunication network connecting the EU/EEA regulatory authorities across a leading market sector.

Could you give us some figures about the use of EudraNet ?

EudraNet connects and provides secure and reliable inter-communication services to 32 organisations including the European Commission, the EMEA and the national regulatory agencies from the EU, Norway and Iceland. The Internet and email domains of most of these organisations are integrated into a collaborative network environment.

The EudraNet network infrastructure guarantees a minimum of 99.4% availability of service and is permanently monitored.

More than 1000 functional email addresses support the activity of 42 Working Groups and Activity Domains. All the officers in the competent authorities in Europe have access and are potential users of EudraNet services.

The data traffic between EudraNet sites presents an increasing pattern since it became operational at the end of 1998. Nowadays it amounts to over 40 Gigabytes per month.

The Commission web site in pharmaceuticals hosted by EudraNet and available through www.eudra.org registers more that 53 000 visitors per month that download over 24 Gigabytes of regulatory and administrative information.

EudraNet hosts :

• 3 basic communication services : EudraMail, EudraSafe and EudraRoom;
• 3 public web sites: Commission’s pharmacos, EMEA and VICH;
• 3 regulatory applications: EudraTrack, Xeddra and Vetmp.

Another application, EudraVigilance, in the pilot phase.

How do the national regulatory agencies integrate EudraNet into their organization ? How do they use it ?

Regulatory agencies connect to EudraNet in various ways. The one by far most widely adopted is that of integrating the local networks into a common environment, thus enabling the direct and secure communication between every officer in each administration.

This integration takes place by having adopted a common naming schema, mutual recognition of local Internet domains, adoption of harmonised functional email addresses and direct communication between local email servers. The result is a secure and reliable environment for desktop-to-desktop electronic communication and sharing of data and electronic documents.

The EC, the EMEA and the national regulatory agencies use EudraNet and EudraSafe in support to all collaborative business processes. More than forty EC, EMEA and MS working groups use EudraMail for exchange of documents relative to meetings or to regulatory procedures, including CPMP and CVMP, Notice to Applicants, inspections, pharmacovigilance, new applications and mutual recognition facilitation groups.

Notably, the decision-making process for marketing authorisation application of medicinal products through the centralised procedure, and in particular the external consultation carried out by the European Commission in co-operation with the EMEA and the Member States represented at the Steering Committees, is done paperless using EudraMail upon EudraNet.

An increasing number of groups use EudraRoom as common repository and to collaborative draft regulatory and scientific documents. Some organisations use EudraSafe to communicate in a secure way with scientific experts in national laboratories not connected to EudraNet and with pharmaceutical companies.

Member States also use EudraNet to populate and consult EudraTrack, which is the tracking system used to register information on mutual recognition procedures, and to access the database of national veterinary medicinal products and the online medical dictionaries.

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19 february 2001