Title:
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MANAGEMENT OF SAFETY INFORMATION FROM CLINICAL TRIALS
REPORT OF CIOMS WORKING GROUP VI |
By: |
Who, World Health Organization, UNAIDS |
Format: |
Paperback |
List price:
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£20.06 |
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ISBN 10: |
9290360798 |
ISBN 13: |
9789290360797 |
Publisher: |
WORLD HEALTH ORGANIZATION |
Pub. date: |
1 June, 2005 |
Pages: |
303 |
Synopsis: |
The membership of CIOMS Working Group VI has been expanded to include regulatory, industry and academic representation with experience in the conduct of clinical trials as well as representatives from less developed regions of the world. In this report they introduce proposals for enhancing the collection, analysis, evaluation, reporting and overall management of safety information from clinical trials. They also discusses the importance of sponsors having a systematic approach to managing risk during development, taking into account non-clinical as well as clinical data. The book is primarily aimed at providing guidance to sponsor of clinical trials, in the hope that the proposals will enhance the ability to protect patient well-being and optimize the development and use of new medicines. |
Publication: |
Switzerland |
Imprint: |
World Health Organization |
Returns: |
Non-returnable |