Pharmacovigilance

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.

This key text is a one-stop source of pharmacovigilance. Its clear sructure, with six main parts, covers all the important aspects of the subject including legal aspects, drug regulatory requirements, methods of signal generation, reporting schemes and pharmacovigilance in selected system-organ classes. The book then goes on to look at possible future directions.*the editors are of excellent standing within the pharmacovigilance community and have chosen the chapter authors with care*the text provides exemplary coverage of all the relevant issues*is the definitive book on the subjectThe book should be in all pharmacovigilance departments, regional pharmacovigilance centres and regulatory authorities. It is an unparalleled source of information and reference for all researchers in pharmacovigilance, pharmaceutical practice and medicine