Improving the Regulatory Review Process - Assessing Performance and Setting Targets (Hardcover, illustrated edition)

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 12th 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 summarizes 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:	Kluwer Academic Publishers
Country of origin:	United States
Series:	Centre for Medicines Research Workshop
Release date:	1998
First published:	1998
Editors:	J.A.Neil McAuslane • Stuart R. Walker
Dimensions:	230mm (L)
Format:	Hardcover
Pages:	192
Edition:	illustrated edition
ISBN-13:	978-0-7923-8731-2
Categories:	Books > Medicine > Other branches of medicine > Pharmacology > General Books > Professional & Technical > Industrial chemistry & manufacturing technologies > Industrial chemistry > Pharmaceutical technology Promotions
LSN:	0-7923-8731-7
Barcode:	9780792387312

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