McAuslane / Walker Improving the Regulatory Review Process: Assessing Performance and Setting Targets

Erscheinungsjahr 2012
ISBN: 978-94-011-4874-0
Verlag: Springer Netherland
Format: PDF
Kopierschutz: 1 - PDF Watermark

E-Book, Englisch, 163 Seiten, eBook

Reihe: Centre for Medicines Research Workshop

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.

Zielgruppe

Research

Autoren/Hrsg.

McAuslane, N.

Walker, S.R.

Inhaltsverzeichnis

1 Assessing performance and setting targets.- 2 Current regulatory reforms and improvements in the review process.- 3 Current regulatory reforms: CBER.- 4 Improving the review process: The view of the Japanese MHW.- 5 Comparing the performance of the Canadian TPD with other regulatory authorities.- 6 Measuring performance: The view of the TGA.- 7 Why have targets for the review process? The view of the EMEA.- 8 Why have targets for the review process? An individual viewpoint.- 9 Key milestones in the regulatory review process.- 10 How do you measure the quality of the scientific assessment and the review process? The view of the MCA.- 11 Ensuring the quality of the scientific assessment and the review process: The FDA’s good review practice initiative.- 12 Outcome of syndicate discussions.- Meeting participants.