Pharmacovigilance PDF Notes | B Pharmacy 8th Semester Noteskarts

Syllabus
Unit: 1

 Introduction to Pharmacovigilance

  • History and development of Pharmacovigilance
  • Importance of safety monitoring of medicines
  • WHO International Drug Monitoring Programme
  • Pharmacovigilance Programme of India (PvPI)

Introduction to Adverse Drug Reactions (ADRs)

  • Definitions and classification of ADRs
  • Detection and reporting of ADRs
  • Methods in causality assessment
  • Severity and seriousness assessment
  • Predictability and preventability assessment
  • Management of adverse drug reactions

Basic Terminologies Used in Pharmacovigilance

    • Terminologies of adverse medication-related events
    • Regulatory terminologies
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Unit: 2

  • 1. Drug and Disease Classification

    • Anatomical, Therapeutic and Chemical (ATC) classification of drugs
    • International Classification of Diseases (ICD)
    • Daily Defined Doses (DDD)
    • International Non-proprietary Names (INN) for drugs

    2. Drug Dictionaries and Coding in Pharmacovigilance

    • WHO Adverse Reaction Terminologies (WHO-ART)
    • MedDRA and Standardized MedDRA Queries (SMQs)
    • WHO Drug Dictionary
    • EudraVigilance Medicinal Product Dictionary

    3. Information Resources in Pharmacovigilance

    • Basic drug information resources
    • Specialized resources for ADRs

    4. Establishing a Pharmacovigilance Programme

    • Establishing a Pharmacovigilance programme in hospitals
    • Establishment and operation of Drug Safety Department in industry
    • Contract Research Organizations (CROs)
    • Establishing a national Pharmacovigilance programme
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Unit: 3

  • Surveillance & Communication in Pharmacovigilance

    1. Vaccine Safety Surveillance

    • Vaccine Pharmacovigilance
    • Vaccination failure
    • Adverse Events Following Immunization (AEFI)

    2. Pharmacovigilance Methods

    Passive Surveillance

    • Spontaneous reports and case series
    • Stimulated reporting

    Active Surveillance

    • Sentinel sites
    • Drug event monitoring
    • Registries

    Comparative Observational Studies

    • Cross-sectional study
    • Case-control study
    • Cohort study

    Other Methods

    • Targeted clinical investigations

    3. Communication in Pharmacovigilance

    • Effective communication in Pharmacovigilance
    • Communication in drug safety crisis management
    • Communicating with:
      • Regulatory agencies
      • Business partners
      • Healthcare facilities
      • Media
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Unit: 4

  • Safety Monitoring & ICH Guidelines 

    1. Safety Data Generation

    • Pre-clinical phase
    • Clinical phase
    • Post-approval phase (PMS)

    2. ICH Guidelines for Pharmacovigilance

    • Organization and objectives of ICH
    • Expedited reporting
    • Individual Case Safety Reports (ICSRs)
    • Periodic Safety Update Reports (PSURs)
    • Post-approval expedited reporting
    • Pharmacovigilance planning
    • Good Clinical Practice (GCP) in Pharmacovigilance studies
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Unit: 5

  • Special Topics in Pharmacovigilance

    1. Pharmacogenomics of ADRs

    • Genetics-related ADRs
    • Examples focusing on pharmacokinetic (PK) parameters

    2. Drug Safety Evaluation in Special Populations

    • Paediatrics
    • Pregnancy and lactation
    • Geriatrics

    3. CIOMS and CDSCO

    CIOMS

    • CIOMS Working Groups
    • CIOMS Form

    CDSCO (India) and Pharmacovigilance

    • Drugs & Cosmetics (D&C) Act and Schedule Y
    • Differences between Indian and global Pharmacovigilance requirements
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