Improving the Regulatory Review Process: Assessing Performance and Setting Targets (1997)Paperback - 1997, 5 November 2012

Improving the Regulatory Review Process: Assessing Performance and Setting Targets (1997)
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Part of Series
Centre for Medicines Research Workshop
Print Length
163 pages
Language
English
Publisher
Springer
Date Published
5 Nov 2012
ISBN-10
9401060428
ISBN-13
9789401060424

Description

At a time when it is becoming usual for medicines to be developed for a global market and pharmaceutical companies are endeavouring to expedite the drug development process, Regulatory Authorities are concentrating on improving their efficiency and effectiveness. Therefore, it is not surprising that questions are being asked as to how performance might be measured and compared between different authorities who are now often in receipt of dossiers that have been submitted to several agencies at the same time. Issues such as 'what target should be set for the review of new medicines?' and `how can quality be assured?' are now considered to be of critical importance.
The twelfth CMR International Workshop, held in January 1997, provided the opportunity for Regulatory Authority and industry personnel from Europe, North America, Australia and Japan to openly discuss experiences and exchange views on how to improve the review process. The proceedings of this meeting provide a comprehensive overview of the current review process in different countries and the need for performance measures and targets. This volume summarises the many suggestions that were debated at the Workshop, and includes chapters on measuring performance, and on the integration of quality into the review process.

Product Details

Abridged:
Book Edition:
1997
Book Format:
Paperback
Country of Origin:
NL
Date Published:
5 November 2012
Dimensions:
23.39 x 15.6 x 1.02 cm
ISBN-10:
9401060428
ISBN-13:
9789401060424
Language:
English
Location:
Dordrecht
Pages:
163
Publisher:
Springer
Weight:
272.16 gm

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