Improving the Regulatory Review Process: Assessing Performance and Setting Targets
Assessing Performance and Setting Targets
1st Edition
Published on 28. February 1998
Book
Hardback
XIX, 163 pages
978-0-7923-8731-2 (ISBN)
Description
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 details
Series
Edition
1., 998
Language
English
Place of publication
Dordrecht
United States
Target group
College/higher education
Professional and scholarly
Research
Product notice
sewn/stitched
Cloth over boards
Illustrations
XIX, 163 p.
index
Dimensions
Height: 241 mm
Width: 160 mm
Thickness: 16 mm
Weight
453 gr
ISBN-13
978-0-7923-8731-2 (9780792387312)
DOI
10.1007/978-94-011-4874-0
Schweitzer Classification
Other editions
Additional editions
N. McAuslane | S.R. Walker
Improving the Regulatory Review Process: Assessing Performance and Setting Targets
Book
11/2012
Springer
€53.49
Shipment within 15-20 days
Content
Preface. Foreword. 1. Assessing Performance and Setting Targets; T. Eaves. 2. Current Regulatory Reforms and Improvements in the Review Process; F. Sauer. 3. Establishing Performance Targets for the Review Process: The View of the FDA; M. Lumpkin. 4. Current Regulatory Reforms: CBER; K. Zoon. 5. Improving the Review Process: The View of the Japanese MHW; Y. Hirayama. 6. Comparing the Performance of the Canadian Therapeutic Products Directorate with Other Regulatory Authorities; B. Pieterson. 7. Measuring Performance: The View of the TGA; J. McEwen. 8. Why Have Targets for the Review Process? The View of the EMEA; R. Bass. 9. Why Have Targets for the Review Process? The European View of a Pharmaceutical Industry Individual; E. Donnelly. 10. Key Milestones in the Regulatory Review Process? The View of the European Pharmaceutical Industry; K. Thomas. 11. How do You Measure the Quality of the Scientific Assessment and the Process? The View of the MCA; D. Jefferys. 12. Ensuring the Quality of the Scientific Assessment and the Review Process: The FDA's Good Review Practice Initiative; M. Lumpkin. 13. Recommendations for the Syndicate Sessions: Define Mutually Agreeable Measures and Targets for the Review Process for Authorising NMEs and Abridged Applications; V. Silano, et al. 14. Recommendations for Syndicate Sessions: What Are the Appropriate Measures of the Quality of the Review; M. Lumpkin, et al. Index.