Librería Samer Atenea
Librería Aciertas (Toledo)
Kálamo Books
Librería Perelló (Valencia)
Librería Elías (Asturias)
Donde los libros
Librería Kolima (Madrid)
Librería Proteo (Málaga)
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.
