Pharmacovigilance Handbook from C.H.I.P.S.

Second edition edited by Ron Mann

Written by an international team of outstanding editors and contributors, Pharmacovigilance, 2nd edition is the definitive text on this important subject.

This new edition has been completely revised and updated to include:

  • legal aspects
  • drug regulatory requirements
  • methods of signal generation
  • reporting schemes
  • pharmacovigilance in selected system-organ classes


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
  6. Harmonisation (Priya Bahri and Panos Tsintis).
  7. Periodic Safety Update Reports
  8. Non-Clinical Safety Evaluation and Adverse Events in Phase I Trials
  9. Mechanisms of Adverse Drug Reactions
  10. Micturin and Torsades de Pointes
  11. Withdrawal of Terodiline: A Tale of Two Toxicities
  12. Nomifensine and Haemolytic Anaemia

Signal Generation

  1. WHO Programme – Global Monitoring
  2. Medical Dictionary for Regulatory Activities (MedDRA®)
  3. Regulatory Pharmacovigilance in the EU
  4. Spontaneous Reporting – UK
  5. Spontaneous Reporting – France
  6. Spontaneous Reporting in Germany
  7. Spontaneous Reporting – United States
  8. Statistical Methods of Signal Detection
  9. Statistical Methods of Evaluating Pharmacovigilance Data
  10. Data Mining in Pharmacovigilance: A View from the Uppsala Monitoring Centre
  11. Pharmacovigilance in the Netherlands
  12. CIOMS Working Groups and their Contribution to Pharmacovigilance
  13. PEM in the UK
  14. PEM in New Zealand
  15. MEMO in the United Kingdom
  16. The General Practice Research Database: Now and the Future
  17. Overview of North American Databases
  18. Other Databases in Europe for the Analytic Evaluation of Drug Effects
  19. Surveillance for Medical Devices – USA
  20. Pharmacovigilance and Risk Management in Japan

Pharmacovigilance and Selected System Organ Classes

  1. Dermatological ADRs
  2. Gastrointestinal ADRs
  3. Haematological ADRs
  4. Hepatic ADRs
  5. Ocular Side Effects of Prescription Medications
  6. Drug Safety in Pregnancy
  7. Renal Adverse Drug Reactions
  8. Anaesthetic Adverse Drug Reactions
  9. Pharmacovigilance in Pediatrics
  10. The Cardiovascular Spectrum of Adverse Drug Reactions
  11. Drugs and the Elderly

Key Current Topics

  1. US Activities in Risk Management of Pharmaceutical Products
  2. Risk Management – a European Regulatory View
  3. The Efficacy and Safety of Selective Serotonin Reuptake Inhibitors for the Treatment of Depression in Children and Adolescents
  4. Pharmacoepidemiology of Hormone Therapy: An Evolving Picture
  5. NSAIDs – COX-2 Inhibitors – Risks and Benefits
  6. Introduction to Pharmionics: The Vagaries in Ambulatory Patients’ Adherence to Prescribed Drug Dosing Regimens, and Some of Their Clinical and Economic Consequences

Lessons and Directions

  1. a. Teaching and Learning Pharmacovigilance
    b. Practical Experience in Teaching Pharmacovigilance
  2. Fatal Medication Errors and Adverse Drug Reactions – Coroners’ Inquests and Other Sources
  3. Pharmacogenetics and the Genetic Basis of ADRs
  4. Keynote Clinical Lessons from Pharmacovigilance


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edited by Ron Mann
2007 • 702 pages • $354.00 + shipping
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