Improving the Regulatory Review Process: Assessing Performance and Setting Targets

. Ed(s): McAuslane, Neil; Walker, S.R.

ISBN 10: 9401060428 / ISBN 13: 9789401060424

Verlag: Springer, 2012

Editor(s): McAuslane, Neil; Walker, S.R. Series: Centre for Medicines Research Workshop. Num Pages: 163 pages, biography. BIC Classification: LNTM; MBN; MMG. Category: (P) Professional & Vocational. Dimension: 240 x 160 x 10. Weight in Grams: 309. . 2012. 1997th Edition. paperback. . . . . Books ship from the US and Ireland. Bestandsnummer des Verkäufers V9789401060424

Inhaltsangabe:

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.

Reseña del editor: 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.

Bibliografische Details

Titel: Improving the Regulatory Review Process: ...
Verlag: Springer
Erscheinungsdatum: 2012
Einband: Softcover
Zustand: New