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4 projets européens trouvés

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 TERMINÉ 

Labeling of Enalapril from Neonates up to Adolescents (LENA)

Date du début: 1 nov. 2013, Date de fin: 31 oct. 2018,

Children are often treated as small adults—not as the special patients they are. Regulations exist to encourage the development of drugs and formulation for children. However, off-patent drugs are often administered to children without appropriate formulations or systematic investigations. Therefore, the paediatric use marketing authorisation (PUMA) has been designed.The EMA Paediatric Working Par ...
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 14

 TERMINÉ 

Pharmaceutical Medicine Training Programme (PHARMATRAIN)

Date du début: 1 mai 2009, Date de fin: 30 avr. 2014,

"The proposed Pharmaceutical Medicine Training Programme provides a comprehensive solution for the complex needs of integrated drug development for all professionals involved, incl. physicians, pharmaceutical scientists,biologists, biometricians, health economists, and safety and regulatory scientists from universities, regulatory agencies, large, middle-sized and small pharmaceutical enterprises, ...
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 52

 TERMINÉ 
The aim of this 3-year Coordination Action will be to identify the patients’ needs for partnership in the clinical trials context. Moreover, this project will lead to both a well-organized and sustainable communication platform and guidelines to enable the mutual beneficial interactions between patients and clinical trials professionals. This aim will be realized through: I) Interviews, addressing ...
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 4

 TERMINÉ 

Impact on Clinical Research of European Legislation (ICREL)

Date du début: 1 janv. 2008, Date de fin: 31 déc. 2008,

"This project aims primarily at analysing and measuring the impact of Directive 2001/20/EC (Clinical Trials Directive, CTD) and related legislation on the industry and academic clinical research with medicinal products but also on their impact on clinical research in the broader sense. This initiative fits with the need to provide evidence for a potential reconsideration of certain aspects of the ...
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 6