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2001/20/EC – A European Directive? por Barbara Römer

26 Dic , 2020    19    0      0 Votos
2001/20/EC – A European Directive? por 
            
                        Barbara Römer

2001/20/EC – A European Directive? por Barbara Römer

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El autor de este libro es

Barbara Römer

Descripción

Sinopsis

Everybody who has performed multi-center clinical trials knows that it is a real challenge to prepare a clinical trial application in different European countries. Frequently asked questions are: Which documents should be included into the submission package? Which timelines apply for the Competent Authority and Ethics Committee evaluation procedure? Are the Competent Authority and Ethics Committee procedures linked together or independent? Regarding the ten European Countries Austria, Belgium, Czech Republic, Germany, Italy, Slovenia, Spain, The Netherlands, Poland and UK your questions will be answered in this book. Beyond the answers to these questions short-, middle- and long-term measures are proposed in order to improve the harmonisation of the clinical trial authorisation procedures in the EU and finally to increase Europe’s attractiveness for clinical research and to ensure global market competitiveness.

Datos del libro
Tectum Wissenschaftsverlag 2011

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