Über den Autor
Dr Patrick Waller has been an independent consultant in pharmacovigilance and pharmacoepidemiology based in Southampton since 2002. He also holds honorary academic appointments at the London School of Hygiene and Tropical Medicine and the University of Dundee. From 1998-2004 he was Visiting Professor in the Department of Pharmacological Sciences at the University of Newcastle-upon-Tyne. From 1990-2002 he worked in the field of pharmacovigilance for the Medicines Control Agency in London. From 1998-2000 he was one of the UK delegates to the Committee for Proprietary Medicinal Products and Chairman of its Pharmacovigilance Working Party.
1: What is pharmacovigilance and how has it developed?.rnOrigins and definition of pharmacovigilance.rnScope and purposes.rnDevelopment of pharmacovigilance since the 1960s.rnConclusion.rn2: Basic concepts.rnIntroduction.rnAdverse Drug Reactions.rnThe concept of safety.rnCausation - was the drug responsible?.rnConclusion.rn3: Types and sources of data.rnIntroduction.rnPre-clinical studies.rnHuman volunteer studies.rnClinical trials.rnPost-marketing surveillance.rnConclusion.rn4: The process of pharmacovigilance.rnOverview - a risk management process.rnSignal detection.rnEvaluation and investigation.rnTaking Action.rnCommunication.rnConclusion.rn5: Regulatory aspects of pharmacovigilance.rnIntroduction.rnLegislation and guidelines.rnRegulatory pharmacovigilance systems.rnObligations of pharmaceutical companies.rnConclusion.rn6: International collaboration.rnIntroduction.rnWorld Health Organisation.rnCouncil for the Organisation of Medical Sciences.rnInternational Conference on Harmonisation.rnConclusion.rn7: Ethical and societal considerations.rnIntroduction.rnStakeholders and their perspectives.rnEthical principles.rnEthical safeguards in relation to safety.rnTransparency.rnConflicts of interest.rnConclusion.rn8: Future Directions.rnIntroduction: current limitations.rnMeeting the challenges.rnConclusion.rn9: Learning more about pharmacovigilance.rnBooks.rnJournals.rnUseful websites.rnCourses.rnInternational societies
Pharmacovigilance is the science and activities relating to the detection, assessment, understanding and prevention of adverse effects or any other drug-related problems.rnThis introductory guide is designed to aid the rapid understanding of the key principles of pharmacovigilance. Packed full of examples illustrating drug safety issues it not only covers the processes involved, but the regulatory aspects and ethical and societal considerations of pharmacovigilance.rnCovering the basics step-by-step, this book is perfect for beginners and is essential reading for those new to drug safety departments and pharmaceutical medicine students.