2001 20 EC - a European directive?
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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.
Nákup knihy
2001 20 EC - a European directive?, Barbara Römer
- Jazyk
- Rok vydání
- 2009
Doručení
Platební metody
2021 2022 2023
Navrhnout úpravu
- Titul
- 2001 20 EC - a European directive?
- Jazyk
- anglicky
- Autoři
- Barbara Römer
- Vydavatel
- Tectum-Verl.
- Rok vydání
- 2009
- ISBN10
- 3828820565
- ISBN13
- 9783828820562
- Kategorie
- Zdraví / Medicína / Lékařství
- Anotace
- 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.