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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.

Funding Scheme

CSC - Cost-sharing contracts

Coordinator

European Communities - Commission of the European Communities - Joint Research Centre (JRC)
Address
Via E. Fermi 1
21020 Ispra
Italy

Participants (10)

AGENCE DU MEDICAMENT
France
Address
143-145,Boulevard Anatole France
93200 Saint-denis
Artificial Intelligence Software Spa
Italy
Address
Via Esterle 9
20132 Milano
BUNDESINSTITUT FUR ARZNEIMITTEL UND MEDIZINPRODUKTE
Germany
Address
10,Seestra_e
13353 Berlin
Glaxo Wellcome Research and Development Ltd
United Kingdom
Address
Greenford Road
UB6 0HE Greenford
HOECHST AKTIENGESELLSCHAFT
Germany
Address
50,Brueninger Strasse, Building H 790
65926 Frankfurt Am Main
JANSSEN PHARMACEUTICA NV
Belgium
Address
30,Turhnoutseweg
2340 Beerse
Medicines Control Agency
United Kingdom
Address
1 Nine Elms Lane
SW8 5NQ London
PHARMACIA AB
Sweden
Address
15,Frosundaviks Alle
17197 Solna Stockholm
SmithKline Beecham plc
United Kingdom
Address
New Frontiers Science Park Third Avenue
CM19 5AW Harlow
ZENTRUM FUER GRAPHISCHE DATENVERARBEITUNG
Germany
Address
7,Wilhelminenstrasse
64283 Darmstadt