Summary and Info
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 About the Author
Terry Eades (born 5 March 1944) is a former Northern Irish professional footballer who played in the Football League for Cambridge United and Watford.He made over 250 appearances in the Football League.After his professional footballing career Terry became player/manager of Histon F.C.Terry is also recognized for scoring the first ever goal on a sunday, in Cambridge United's 2-2 draw with Oldham F.C.
Review and Comments
Rate the Book
Improving the Regulatory Review Process: Assessing Performance and Setting Targets 0 out of 5 stars based on 0 ratings.