Improving the Regulatory Review Process: Assessing Performance and Setting Targets (Paperback, Softcover reprint of the original 1st ed. 1997)

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.

General

Imprint:	Springer
Country of origin:	Netherlands
Series:	Centre for Medicines Research Workshop
Release date:	November 2012
First published:	1997
Editors:	N. McAuslane • S.R. Walker
Dimensions:	240 x 160 x 10mm (L x W x T)
Format:	Paperback
Pages:	163
Edition:	Softcover reprint of the original 1st ed. 1997
ISBN-13:	978-9401060424
Categories:	Books > Law > Laws of other jurisdictions & general law > Social law > General Books > Medicine > General issues > Public health & preventive medicine > General Books > Medicine > Other branches of medicine > Pharmacology > General Promotions
LSN:	9401060428
Barcode:	9789401060424

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