Improving the Regulatory Review Process: Assessing Performance and Setting Targets

ISBN-13: 9780792387312 / Angielski / Twarda / 1998 / 163 str.

McAuslane; Neil McAuslane; Stuart R. Walker

Opis

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.

Spis treści

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.