Improving the Regulatory Review Process

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.