Pharmacovigilance

Description based upon print version of record.

52. Keynote Clinical Lessons from Pharmacovigilance.

Written by an international team of outstanding editors and contributors, Pharmacovigilance, 2nd Edition is the definitive text on this important subject. The new edition has been completely revised and updated to include the latest theoretical and practical aspects of pharmacovigilance including legal issues, drug regulatory requirements, methods of signal generation, reporting schemes and pharmacovigilance in selected system-organ classes. . The editors and contributors are of excellent standing within the pharmacovigilance communityThe tex.

Pharmacovigilance; Contents; Contributors; Preface; Foreword; Part I. The Basis of Pharmacovigilance; 1. Introduction; 2. Legal Basis -- EU; 3. Legal Basis -- United States; 4. Ethical Oversight, Consent and Confidentiality; 5. Pharmacovigilance-Related Topics at the Level of the International Conference on Harmonisation; 6. Periodic Safety Update Reports; 7. Non-Clinical Safety Evaluation and Adverse Events in Phase I Trials; 8. Mechanisms of Adverse Drug Reactions; 9. Micturin and Torsades de Pointes; 10. Withdrawal of Terodiline: A Tale of Two Toxicities

11. Nomifensine and Haemolytic AnaemiaPart II. Signal Generation; 12. WHO Programme -- Global Monitoring; 13. Medical Dictionary for Regulatory Activities (MedDRA®); 14. Regulatory Pharmacovigilance in the EU; 15. Spontaneous Reporting -- UK; 16. Spontaneous Reporting -- France; 17. Spontaneous Reporting in Germany; 18. Spontaneous Reporting -- United States; 19. Statistical Methods of Signal Detection; 20. Statistical Methods of Evaluating Pharmacovigilance Data; 21. Data Mining in Pharmacovigilance: A View from the Uppsala Monitoring Centre; 22. Pharmacovigilance in the Netherlands

23. CIOMS Working Groups and their Contrib…