MARKET AUTHORIZATION BY NETWORK SUBMISSION AND EVALUATION

Objective

The aim of MANSEV is the design and implementation of a novel electronic submission system adapted to new EU drug regulatory procedures. Using the network infrastructure of the EU regulatory authorities, the system will be designed as an interchange module between pharmaceutical companies and the authorities with whose application tracking facilities it will be integrated. Implemented by means of Internet Web technologies, the project is expected to result in a fully functional pilot system for initially limited verification and, following its completion, possibly extensive use in pharmaceuticals production. MANSEV participates in the project cluster entitled: ACTION for Telematics Applications for Cooperative work of Healthcare Professionals.

Programme(s)

• FP4-TELEMATICS 2C - Specific programme of research and technological development and demonstration in the area of telematic applications of common interest, 1994-1998

Topic(s)

• C.7 - Telematics Applications for Healthcare

Funding Scheme

Coordinator

Participants (10)