Pharmacovigilance, 2nd Edition

"Pharmacovigilance is an excellent and detailed examination of the current state of both science and practice." (The Pharmaceutical Journal, November 2007)

Ronald D. Mann, Professor Emeritus, University of Southampton, UK. Elizabeth B. Andrews, RTI Health Solutions, Research Triangle Institute, UNC School of Public Health and School of Pharmacy, NC, USA

Contributors. Preface. Foreword. PART I. THE BASIS OF PHARMACOVIGILANCE. 1. Introduction (Ronald D. Mann and Elizabeth B. Andrews). 2. Legal Basis - EU (Nicholas Macfarlane, Paul Brown, Caroline Moore, Claire Taylor, Uwe Froehlich, Tanja Barton, Olivier Banchereau and Paola La Licata). 3. Legal Basis - United States (Jayne P. Bultena). 4. Ethical Oversight, Consent and Confidentiality (Donna A. Boswell and Elizabeth B. Andrews). 5. Pharmacovigilance-Related Topics at the Level of the International Conference on Harmonisation (Priya Bahri and Panos Tsintis). 6. Periodic Safety Update Reports (Patrice Verpillat and Mondher Toumi). 7. Non-Clinical Safety Evaluation and Adverse Events in Phase I Trials (Patricia M. Reed, Stuart J. Mair and Stephen Freestone). 8. Mechanisms of Adverse Drug Reactions (Munir Pirmohamed and B. Kevin Park). 9. Micturin and Torsades de Pointes (Richard N. Wild). 10. Withdrawal of Terodiline: A Tale of Two Toxicities (Rashmi R. Shah). 11. Nomifensine and Haemolytic Anaemia (Peter D. Stonier and J. Guy Edwards). PART II. SIGNAL GENERATION. 12. WHO Programme - Global Monitoring (I. Ralph Edwards and Cecilia Biriell). 13. Medical Dictionary for Regulatory Activities (MedDRA(r)) (Elliot Brown). 14. Regulatory Pharmacovigilance in the EU (Priya Bahri, Panos Tsintis and Patrick C. Waller). 15. Spontaneous Reporting - UK (Sarah Davis, Bridget King and June M. Raine). 16. Spontaneous Reporting - France (Nicholas Moore, Carmen Kreft-Jais and Alban Dhanani). 17. Spontaneous Reporting in Germany (Ulrich Hagemann and Norbert Paeschke). 18. Spontaneous Reporting - United States (David J. Graham, Syed R. Ahmad and Toni Piazza-Hepp). 19. Statistical Methods of Signal Detection (Stephen Evans). 20. Statistical Methods of Evaluating Pharmacovigilance Data (Bernard Begaud). 21. Data Mining in Pharmacovigilance: A View from the Uppsala Monitoring Centre (I. Ralph Edwards, Marie Lindquist, Andrew Bate and G. Niklas Noren). 22. Pharmacovigilance in the Netherlands (Kees van Grootheest and Eugene van Puijenbroek). 23. CIOMS Working Groups and their Contribution to Pharmacovigilance (Sue Roden and Trevor Gibbs). 24. PEM in the UK (Saad A.W. Shakir). 25. PEM in New Zealand (Mira Harrison-Woolrych and David M. Coulter). 26. MEMO in the United Kingdom (Douglas Steinke, Josie M.M. Evans and Thomas M. Macdonald). 27. The General Practice Research Database: Now and the Future (John Parkinson, Sarah Davis and Tjeerd Van Staa). 28. Overview of North American Databases (Brian L. Strom and Judith L. Kinman). 29. Other Databases in Europe for the Analytic Evaluation of Drug Effects (Miriam C.J.M. Sturkenboom). 30. Surveillance for Medical Devices - USA (Thomas P. Gross). 31. Pharmacovigilance and Risk Management in Japan (Kiyoshi Kubota and Hiroko Koyama). PART III. PHARMACOVIGILANCE AND SELECTED SYSTEM ORGAN CLASSES. 32. Dermatological ADRs (Laurence Allanore-Valeyrie and Jean-Claude Roujeau). 33. Gastrointestinal ADRs (John R. Wood and Graham A. Pipkin). 34. Haematological ADRs (Peter J. Carey). 35. Hepatic ADRs (Guruprasad P. Aithal and Christopher P. Day). 36. Ocular Side Effects of Prescription Medications (F.W. Fraunfelder). 37. Drug Safety in Pregnancy (Christina D. Chambers and Elizabeth B. Andrews). 38. Renal Adverse Drug Reactions (Gert A. Verpooten). 39. Anaesthetic Adverse Drug Reactions (Anita Holdcroft). 40. Pharmacovigilance in Pediatrics (Solomon Iyasu and M. Dianne Murphy). 41. The Cardiovascular Spectrum of Adverse Drug Reactions (Judith Hsia, Jinping Mo, Laura Burleson and Annlouise R. Assaf). 42. Drugs and the Elderly (Una Martin and Jamie J. Coleman). PART IV. KEY CURRENT TOPICS. 43. US Activities in Risk Management of Pharmaceutical Products (Jonca Bull). 44. Risk Management - a European Regulatory View (June M. Raine). 45. The Efficacy and Safety of Selective Serotonin Reuptake Inhibitors for the Treatment of Depression in Children and Adolescents (Julie Magno Zito and