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Improving the Regulatory Review Process: Assessing Performance and Setting Targets (Centre for Medicines Research Workshop) - Softcover
Synopsis
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.
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Improving the Regulatory Review Process: Assessing Performance and Setting Targets (Centre for Medicines Research Workshop)
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Improving the Regulatory Review Process: Assessing Performance and Setting Targets: Assessing Performance and Setting Targets (Centre for Medicines Research Workshop)
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Improving the Regulatory Review Process: Assessing Performance and Setting Targets
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Taschenbuch. Condition: Neu. This item is printed on demand - it takes 3-4 days longer - Neuware -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. 188 pp. Englisch. Seller Inventory # 9789401060424
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Improving the Regulatory Review Process : Assessing Performance and Setting Targets
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Improving the Regulatory Review Process: Assessing Performance and Setting Targets
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Condition: New. 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. . . . . Seller Inventory # V9789401060424
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Improving the Regulatory Review Process: Assessing Performance and Setting Targets
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Taschenbuch. Condition: Neu. Druck auf Anfrage Neuware - Printed after ordering - 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. Seller Inventory # 9789401060424
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Improving the Regulatory Review Process: Assessing Performance and Setting Targets: Assessing Performance and Setting Targets (Centre for Medicines Research Workshop)
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