Improving the Regulatory Review Process: Assessing Performance and Setting Targets

Nonfiction, Reference & Language, Law, Medical Law & Legislation, Health & Well Being, Medical, Medical Science, Pharmacology
Cover of the book Improving the Regulatory Review Process: Assessing Performance and Setting Targets by , Springer Netherlands
View on Amazon View on AbeBooks View on Kobo View on B.Depository View on eBay View on Walmart
Author: ISBN: 9789401148740
Publisher: Springer Netherlands Publication: December 6, 2012
Imprint: Springer Language: English
Author:
ISBN: 9789401148740
Publisher: Springer Netherlands
Publication: December 6, 2012
Imprint: Springer
Language: English

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.

View on Amazon View on AbeBooks View on Kobo View on B.Depository View on eBay View on Walmart

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.

More books from Springer Netherlands

Cover of the book Assessment of Tumour Response by
Cover of the book The Planning Theory of Law by
Cover of the book The Nature of the Doctor-Patient Relationship by
Cover of the book Land Degradation by
Cover of the book Sustainable Potato Production: Global Case Studies by
Cover of the book The Bedrock of Opinion by
Cover of the book Studies in Inherited Metabolic Disease by
Cover of the book Sustainable Development of European Cities and Regions by
Cover of the book Value Theory and Economic Progress: The Institutional Economics of J. Fagg Foster by
Cover of the book After Popper, Kuhn and Feyerabend by
Cover of the book Post-War International Civil Aviation Policy and the Law of the Air by
Cover of the book Mycobacterial Skin Diseases by
Cover of the book Essentials of Tissue Banking by
Cover of the book Issues and Challenges in Science Education Research by
Cover of the book The Strategy of Life by
We use our own "cookies" and third party cookies to improve services and to see statistical information. By using this website, you agree to our Privacy Policy