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Pharmacovigilance, 2nd Edition

Pharmacovigilance, 2nd Edition

Ronald D. Mann (Editor), Elizabeth B. Andrews (Editor)

ISBN: 978-0-470-05922-7

Feb 2007

702 pages



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 community
  • The text provides exemplary coverage of all the relevant issues
  • The definitive book on the subject




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).


12. WHO Programme – Global Monitoring (I. Ralph Edwards and Cecilia Biriell).

13. Medical Dictionary for Regulatory Activities (MedDRA®) (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 Bégaud).

21. Data Mining in Pharmacovigilance: A View from the Uppsala

Monitoring Centre (I. Ralph Edwards, Marie Lindquist, Andrew Bate and G. Niklas Norén).

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).


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).


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 Daniel J. Safer).

46. Pharmacoepidemiology of Hormone Therapy: An Evolving Picture (Annlouise R. Assaf, Laura E. Burleson and Joann E. Manson).

47. NSAIDs – COX-2 Inhibitors – Risks and Benefits (K. Arnold Chan and S. Christopher Jones).

48. Introduction to Pharmionics: The Vagaries in Ambulatory Patients’ Adherence

to Prescribed Drug Dosing Regimens, and Some of Their Clinical and Economic Consequences (John Urquhart and Bernard Vrijens).


49. Teaching and Learning Pharmacovigilance (Frank May).

49b. Practical Experience in Teaching Pharmacovigilance (Stephen Evans).

50. Fatal Medication Errors and Adverse Drug Reactions – Coroners’ Inquests

and Other Sources (R.E. Ferner, S.E. McDowell and A.K. Cotter).

51. Pharmacogenetics and the Genetic Basis of ADRs (Penelope K. Manasco).

52. Keynote Clinical Lessons from Pharmacovigilance (David H. Lawson and Keith Beard).


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