Keynote abstract
The Network of European Drug Regulatory Agency, EUDRA, the European Commission and the European Medicines Agency, EMEA, agreed to put in place a small number of information systems of high European value to help protect public health, implement EU legislation and policies and to improve the efficient running of EU procedures. In 2002, EU Member State Regulatory Agencies and the European Commission asked the EMEA to take over the development and operation of most of the EU Telematics systems from 1 January 2003. The EMEA Management Board accepted this proposal in December 2002 and EMEA took on the responsibility for EU Telematics as planned on 1 January 2003.
With the release of EudraGMP on 27 April 2007 all EU Telematics systems are in operation, albeit not all of them with the full functionality originally planned.
After a brief overview of the regulatory processes for medicinal products in the EU this presentation describes the EU Telematics systems, explains the main arguments justifying their development and operation with practical examples of use cases, and finally gives an outlook on further development plans and challenges for the future.
