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European Modular Education and Training Programme in Safety Sciences for Medicines

Objective

Background:
In current drug safety education and training in Europe, an integrative and translational approach is lacking. This shortfall has been identified by EUFEPS. The IMI (‘Strategic Research Agenda’), the FDA and the EMEA have also characterised this fact as a crucial gap in the education and training of scientists evaluating the safety of drug candidates and new medicines.

Scope and objectives:
We present a new and unique pan-European education and training network, which solves this shortfall by developing and establishing a comprehensive modular Education and Training Programme in Safety Sciences for Medicines (SafeSciMET). This programme will fulfil the needs of pharmaceutical industry, regulatory authorities and academia. The network, consisting of top institutes for drug safety education and research, proposes a new type, high quality and sustainable programme for education and training in Safety Sciences for Medicines (S2M). The tailor-made training modules will encompass the safety, ethical, regulatory and societal aspects in all phases of drug development, with emphasis on integrative, translational and 3Rs aspects of drug safety assessment. Individual safety professionals who wish to address specific knowledge gaps will be able to follow single modules. The modular set up also provides an excellent opportunity for following dedicated sub-sets of modules, to be accredited for Continuing Professional Development (CPD). Scientists successfully completing the full programme, including an integrative MSc-thesis, will be awarded with an accredited Master of Advanced Safety Sciences of Medicines (M4S2M). All training modules and procedures will be aligned with the Bologna process.

Principle learning outcomes are novel competences in translational safety sciences, leading to safety scientists who are able to perform holistic and critical evaluations of the safety of drug candidates and new medicines by linking of animal and patient data.

Field of science

  • /medical and health sciences/basic medicine/pharmacology and pharmacy/drug safety

Call for proposal

IMI-JU-01-2008
See other projects for this call

Funding Scheme

JTI-CP-IMI - Joint Technology Initiatives - Collaborative Project (IMI)

Coordinator

F. HOFFMANN-LA ROCHE AG
Address
Grenzacherstrasse 124
4070 Basel
Switzerland
Activity type
Private for-profit entities (excluding Higher or Secondary Education Establishments)
Principal investigator
Manfred Kansy (Dr.)
Administrative Contact
Manfred Kansy (Dr.)

Participants (32)

STICHTING VU
Netherlands
EU contribution
€ 767 305
Address
De Boelelaan 1105
1081 HV Amsterdam
Activity type
Higher or Secondary Education Establishments
Administrative Contact
Bart van Leijen (Mr)
UNIVERSITAT KONSTANZ
Germany
EU contribution
€ 531 300
Address
Universitatsstrasse 10
78464 Konstanz
Activity type
Higher or Secondary Education Establishments
Administrative Contact
Gertraud Plaza Pascual (Mrs)
UNIVERSITY OF SURREY
United Kingdom
EU contribution
€ 47 867
Address
Stag Hill
GU2 7XH Guildford
Activity type
Higher or Secondary Education Establishments
Administrative Contact
SUE ANGULATTA (MS)
UPPSALA UNIVERSITET
Sweden
EU contribution
€ 485 506
Address
Von Kraemers Alle 4
751 05 Uppsala
Activity type
Higher or Secondary Education Establishments
Administrative Contact
Agneta Hortlund (Ms)
European Federation for Pharmaceutical Sciences
Sweden
EU contribution
€ 231 400
Address
Veddestavägen
SE-175 62 Järfälla, Stockholm
Administrative Contact
Hans H Linden (Mr)
KOBENHAVNS UNIVERSITET
Denmark
EU contribution
€ 52 200
Address
Norregade 10
1165 Kobenhavn
Activity type
Higher or Secondary Education Establishments
Administrative Contact
Kenneth Lindholm (Mr)
UNIVERSITEIT LEIDEN
Netherlands
EU contribution
€ 64 300
Address
Rapenburg 70
2311 EZ Leiden
Activity type
Higher or Secondary Education Establishments
Administrative Contact
Ine Goedegebuur (Dr)
STICHTING LYGATURE
Netherlands
EU contribution
€ 20 727
Address
Jaarbeursplein 6
3521 AL Utrecht
Activity type
Other
Administrative Contact
Daniël Jan Anne Crommelin (Prof. Dr.)
UNIVERSITAT BASEL

Participation ended

Switzerland
Address
Petersplatz 1
4051 Basel
Activity type
Higher or Secondary Education Establishments
Administrative Contact
Fritz R Bühler (Prof. Dr.)
UNIVERSITE DE LORRAINE
France
EU contribution
€ 1 665
Address
Cours Leopold 34
54052 Nancy Cedex
Activity type
Higher or Secondary Education Establishments
Administrative Contact
Nicolas DUPUY (Dr)
HOSPICES CIVILS DE LYON
France
EU contribution
€ 26 027
Address
Quai Des Celestins 3
69002 Lyon
Activity type
Public bodies (excluding Research Organisations and Secondary or Higher Education Establishments)
Administrative Contact
Cécile Legros (Ms)
MARTIN-LUTHER-UNIVERSITAET HALLE-WITTENBERG
Germany
EU contribution
€ 21 800
Address
Universitaetsplatz 10
6108 Halle (Saale)
Activity type
Higher or Secondary Education Establishments
Administrative Contact
Sigrid Köhne (Dr)
KAROLINSKA INSTITUTET
Sweden
EU contribution
€ 21 400
Address
Nobels Vag 5
17177 Stockholm
Activity type
Higher or Secondary Education Establishments
Administrative Contact
Stefan Eriksson (Dr)
UNIVERSITAT WIEN
Austria
EU contribution
€ 34 800
Address
Universitatsring 1
1010 Wien
Activity type
Higher or Secondary Education Establishments
Administrative Contact
Heinz W. Engl (Prof.)
UNIVERSITE PARIS-SUD
France
EU contribution
€ 2 340
Address
Rue Georges Clemenceau 15
91405 Orsay Cedex
Activity type
Higher or Secondary Education Establishments
Administrative Contact
Eric Franqueville (Dr)
THE UNIVERSITY OF LIVERPOOL
United Kingdom
EU contribution
€ 27 225
Address
Brownlow Hill 765 Foundation Building
L69 7ZX Liverpool
Activity type
Higher or Secondary Education Establishments
Administrative Contact
Neil French (Dr)
University of Lisboa, Faculty of Pharmacy (Faculdade de Farmácia da Universidade de Lisboa)
Portugal
EU contribution
€ 20 727
Address
Avenida Prof. Gama Pinto
1649-003 Lisboa
Administrative Contact
José Morais (Professor)
CHARITE - UNIVERSITAETSMEDIZIN BERLIN
Germany
EU contribution
€ 18 315
Address
Chariteplatz 1
10117 Berlin
Activity type
Higher or Secondary Education Establishments
Administrative Contact
Eveline Frässdorf (Ms.)
ASTRAZENECA AB
Sweden
Address
Vastra Maelarhamnen
151 85 Sodertaelje
Activity type
Private for-profit entities (excluding Higher or Secondary Education Establishments)
Administrative Contact
Mike Hardman (Dr)
ALMIRALL SA
Spain
Address
General Mitre 151
08022 Barcelona
Activity type
Private for-profit entities (excluding Higher or Secondary Education Establishments)
Administrative Contact
Jose-Luis Diaz (Dr)
SANOFI-AVENTIS RECHERCHE & DEVELOPPEMENT
France
Address
Pierre Brossolette 1
91380 Chilly Mazarin
Activity type
Private for-profit entities (excluding Higher or Secondary Education Establishments)
Administrative Contact
Frédéric Galli (Dr)
Bayer Pharma AG
Germany
Address
Muellerstrasse 178
13353 Berlin
Activity type
Private for-profit entities (excluding Higher or Secondary Education Establishments)
Administrative Contact
Freitag Petra (Ms)
BOEHRINGER INGELHEIM INTERNATIONALGMBH
Germany
Address
Binger Strasse
55218 Ingelheim
Activity type
Private for-profit entities (excluding Higher or Secondary Education Establishments)
Administrative Contact
Marcus Kostka (Dr.)
Eli Lilly and Company Limited
United Kingdom
Address
Lilly House, Priestley Road
RG24 9NL Basingstoke
Activity type
Private for-profit entities (excluding Higher or Secondary Education Establishments)
Administrative Contact
Birgit Steckel-Hamann (Dr.)
PFIZER LIMITED

Participation ended

United Kingdom
Address
Ramsgate Road
CT13 9NJ Sandwich
Activity type
Private for-profit entities (excluding Higher or Secondary Education Establishments)
Administrative Contact
Olga Krylova (Dr)
GLAXOSMITHKLINE RESEARCH AND DEVELOPMENT LTD.
United Kingdom
Address
Great West Road 980
TW89GS Brentford
Activity type
Private for-profit entities (excluding Higher or Secondary Education Establishments)
Administrative Contact
Sally Miles (-)
H. LUNDBECK AS
Denmark
Address
Ottiliavej 7-9
2500 Valby
Activity type
Private for-profit entities (excluding Higher or Secondary Education Establishments)
Administrative Contact
Ejner Moltzen (Mr)
Merck KGaA
Germany
Address
Frankfurter Strasse 250
64293 Darmstadt
Activity type
Private for-profit entities (excluding Higher or Secondary Education Establishments)
Administrative Contact
Ninog Péresse (Mrs.)
UCB BIOPHARMA SRL
Belgium
Address
Allee De La Recherche 60
1070 Bruxelles
Activity type
Private for-profit entities (excluding Higher or Secondary Education Establishments)
Administrative Contact
Simon DRESSE (Mr.)
NOVARTIS PHARMA AG
Switzerland
Address
Lichtstrasse 35
4056 Basel
Activity type
Private for-profit entities (excluding Higher or Secondary Education Establishments)
Administrative Contact
Barbara Stolz (Dr)
NOVO NORDISK A/S
Denmark
Address
Novo Alle 1
2880 Bagsvaerd
Activity type
Private for-profit entities (excluding Higher or Secondary Education Establishments)
Administrative Contact
Jorgen Dirach (Dr)
ORION OYJ
Finland
Address
Orionintie 1
02200 Espoo
Activity type
Private for-profit entities (excluding Higher or Secondary Education Establishments)
Administrative Contact
Reijo Salonen (Dr)