Interest in the field of pharmacovigilance has grown rapidly in recent years with the possible toxicity of a drug becoming as much a focus of clinical trials as its benefits. This key text is a definitive resource for professionals working within pharmacovigilance. Written by leading professionals in the field, its clear structure, covers all the important aspects of the subject including:- Legal aspects Drug regulatory requirements Methods of signal generation Reporting schemes Pharmacovigilance in selected system-organ classes Future directions This comprehensive 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.

Table of Contents:
List of Contributors.Preface. Foreword. PART I: BASIS OF PHARMACOVIGILANCE. Introduction (R. Mann and E. Andrews). Legal Basis--EU (N. Macfarlane, et al.). Legal Basis--US (R. Brady and M. Learn). Ethical Oversight, Consent and Confidentiality (D. Boswell and E. Andrews). Pre clinical Safety Evaluation (N. Kellet, S. Mair and W. Nimmo). Metabolic Mechanisms (M. Pirmohamed and B. Park). Drugs and the Elderly (U. Martin and C. George). Natural History (P. Stang). Responding to Signals (P. Waller and P. Arlett). Micturin and Torsades de Pointes (R. Wild). Withdrawal of Terodiline: A Tale of Two Toxicities (R. Shah). Nomifensine and Haemolytic Anaemia (P. Stonier and J. Edwards). PART II: SIGNAL GENERATION. WHO Programme--Global Monitoring (I. Edwards and S. Olsson). Regulatory Pharmacovigilance in the EU (P. Waller and P. Bahri). Spontaneous Reporting--UK (S. Davis and J. Raine). Spontaneous Reporting--France (N. Moore, C. Kreft Jais and A. Dahnani). Spontaneous Reporting--USA (D. Graham, S. Ahmad and T. Piazz Hepp). Algorithms (J. Clark). Overview--Spontaneous Signalling (J. Clark, S. Klincewicz and P. Stang). Statistical Methods of Signal Detection (S. Evans). Statistical Methods of Evaluating Pharmacovigilance Data (B. Begaud). Data Mining (I. Edwards et al.). Epidemiology of Adverse Events Associated with Epilepsy and Use of Lamotrigine (P. Tennis). Pharmacovigilance in the Netherlands (A. van Grootheest and E. van Puijenbroek). CIOMS Working Groups and their Contribution to Pharmacovigilance (S. Roden). PEM in the UK (S. Shakir). PEM in New Zealand (D. Coulter). MEMO in the UK (D. Steinke, J. Evan and T. Macdonald). GPRD in the UK (L. Wood). Overview of North American Databases (B. Storm and J. Kinman). Pharmacovigilance in the HMO Research Network (R. Platt et al.). Other Databases in Europe (M. Sturkenboom). Surveillance for Medical Devices--USA (T. Gross and L. Kessler). PART III: PHARMACOVIGILANCE AND SELECTED SYSTEM ORGAN CLASSES. Dermatological ADRs (L. Valeyrie and J. C. Roujeau). Gastrointestinal ADRs (J. Wood and G. Pipkin). Haematological ADRs (S. Davis and R. Mann). Hepatic Adverse Drug Reactions (G. Aithal and C. Day). Ocular ADRs (F.W. Fraunfelder and F.T. Fraunfelder). Drug Safety in Pregnancy (C. Chambers and E. Andrews). ADRs and Drug Safety 1999 2000 (P. Curel and R. Stather). PART IV: LESSONS AND DIRECTIONS. Teaching Pharmacovigilance (R. Meyboom, S. Olsson and M. Thorogood). Medical Errors and Lessons from Drug Related Deaths (R. Ferner and R. Whittington). Pharmacogenetics and the Genetic Basis of ADRs (P. Manasco et al.). Keynote Clinical Lessons from Pharmacovigilance (D. Lawson). Index.