Pharmacovigilance Books Free Download

Download Pharmacovigilance Books PDF For Free. In this post of MyPharmaGuide, we have shared Free Books For the subject of Pharmacovigilance. All these books going to be extremely helpful for your studies. So Download them for free and start learning. Pharmacovigilance is the science and activity which is related to the detection, assessment, understanding, and prevention of adverse effects or any other medicine/vaccine-related problems.

Pharmacovigilance Books Free Download
Pharmacovigilance Books Free Download

A Practical Guides On Pharmacovigilance For Beginners

Book NameA Practical Guides On Pharmacovigilance For Beginners
PublishersTaramani Magalir Co-operative Press
LinkClick Here to Download

Contents of this book are:

  • Standard Terms & Definitions in Pharmacovigilance
  • Global perspective of Pharmacovigilance
  • Domestic perspective of Pharmacovigilance
  • Guidelines and laws governing Pharmacovigilance
  • Global Adverse Event Reporting systems and Reporting forms
  • Individual Case Safety Reports
  • Periodic Safety Update Reports
  • Answers for Case studies
  • Answers for Exercise based Questions
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Publishers NameJohn Wiley & Sons Ltd
: LinkClick Here to Download

Contents of this book are:

  • Introduction
  • Legal Basis – EU
  • Legal Basis – United States
  • Ethical Oversight, Consent and Confidentiality
  • Pharmacovigilance-Related Topics at the Level of the International Conference on Harmonisation
  • Periodic Safety Update Reports
  • Non-Clinical Safety Evaluation and Adverse Events in Phase I Trials
  • Mechanisms of Adverse Drug Reactions
  • Micturin and Torsades de Pointes
  • Withdrawal of Terodiline: A Tale of Two Toxicities
  • Nomifensine and Haemolytic Anaemia
  • WHO Programme – Global Monitoring
  • Medical Dictionary for Regulatory Activities (MedDRA®)
  • Regulatory Pharmacovigilance in the EU
  • Spontaneous Reporting – UK
  • Spontaneous Reporting – France
  • Spontaneous Reporting in Germany
  • Spontaneous Reporting – United States
  • Statistical Methods of Signal Detection
  • Statistical Methods of Evaluating Pharmacovigilance Data
  • Data Mining in Pharmacovigilance: A View from the Uppsala Monitoring Centre
  • Pharmacovigilance in the Netherlands
  • CIOMS Working Groups and their Contribution to Pharmacovigilance
  • PEM in the UK
  • PEM in New Zealand
  • MEMO in the United Kingdom
  • The General Practice Research Database: Now and the Future
  • Overview of North American Databases
  • Other Databases in Europe for the Analytic Evaluation of Drug Effects
  • Surveillance for Medical Devices – USA
  • Pharmacovigilance and Risk Management in Japan
  • Dermatological ADRs
  • Gastrointestinal ADRs
  • Haematological ADRs
  • Hepatic ADRs
  • Ocular Side Effects of Prescription Medications
  • Drug Safety in Pregnancy
  • Renal Adverse Drug Reactions
  • Anaesthetic Adverse Drug Reactions.
  • Pharmacovigilance in Pediatrics
  • The Cardiovascular Spectrum of Adverse Drug Reactions
  • Drugs and the Elderly
  • US Activities in Risk Management of Pharmaceutical Products
  • Risk Management – a European Regulatory View
  • The Efficacy and Safety of Selective Serotonin Reuptake Inhibitors for the Treatment of Depression in Children and Adolescents
  • Pharmacoepidemiology of Hormone Therapy: An Evolving Picture
  • NSAIDs – COX-2 Inhibitors – Risks and Benefits
  • Introduction to Pharmionics: The Vagaries in Ambulatory Patients’ Adherence to Prescribed Drug Dosing Regimens, and Some of Their Clinical and Economic Consequences
  • Teaching and Learning Pharmacovigilance
  • Practical Experience in Teaching Pharmacovigilance
  • Fatal Medication Errors and Adverse Drug Reactions – Coroners’ Inquests and Other Sources
  • Pharmacogenetics and the Genetic Basis of ADRs
  • Keynote Clinical Lessons from Pharmacovigilance
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A Practical Handbook on the Pharmacovigilance of Antiretroviral Medicines

Book NameA Practical Handbook on the Pharmacovigilance of Antiretroviral Medicines
AuthorsWorld Health Organization
PublishersWorld Health Organization
LinkClick Here to Download

The contents of this book are:

  • Pharmacovigilance
  • Pharmacovigilance centre
  • Passive pharmacovigilance
  • Active pharmacovigilance
  • Introduction
  • Objectives
  • Minimum reporting requirements
  • How to report
  • Where to report
  • What to report
  • When to report
  • Who should report
  • Sharing the results
  • Data entry
  • ntroduction
  • Epidemiology
  • First step – Implementation
  • Second step – establishing the cohort(s)
  • Third step – acquiring the data The medicines
  • The events
  • Database for CEM
  • Maximizing the reporting rate
  • General advice and information
  • Fourth step – Clinical review
  • Data entry
  • Quality control
  • Coding of medicines and diseases
  • Using CemFlow
  • Collating and summarizing the events
  • Serious events
  • Pregnancies
  • Lactation exposure
  • Deaths
  • Lack of efficacy
  • Late onset reactions
  • Concomitant morbid conditions
  • Relationship/Causality assessment
  • Signal identification
  • Strengthening the signal
  • Identifying risk factors
  • Analyses
  • Differences between spontaneous reporting and CEM
  • Organization
  • Communication
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MindMaps of Pharmacovigilance Basics

Book NameMindMaps of Pharmacovigilance Basics
AuthorsAmrita Akhori
LinkClick Here to Download


  • Introduction to Drug Development Process
  • History of Pharmacovigilance
  • Pharmacovigilance
  • Reporting of Adverse Reactions and Adverse Events
  • Post Marketting Survellance
  • MedDRA
  • Casuality Assessment
  • Signal Management Process
  • Risk Management Plan
  • Labelling
  • Short Notes
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Pharmacovigilance Nirali

Book NamePharmacovigilance for 8th Semester
Total Pages262
LinkClick Here to Download


  • Introduction to Pharmacovigilance
  • Introduction to Adverse Drug Reactions
  • Basic Terminologies Used in Pharmacovigilance
  • Drug and Disease Classification
  • Drug Dictionaries and Coding in Pharmacovigilance
  • Establisihing Pharmacovigilance Programme
  • Vaccine and Safety Survellance
  • Pharmacovigilance Method
  • Communication in Pharmacovigilance
  • Statistical MEthods for Evaluating Medication Safety Data Data Generation
  • ICH Guidelines for Pharmacovigilance
  • Pharmacogenomics of Adverse Drug Reaction, Drug Safety Evaluation in special population
  • CDSO (India) and Pharmacovigilance
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