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WOOCS 2.1.5.4
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    Course Syllabus

    A Introduction

    Pharmacovigilance
    General aims
    Specific aims
    Pharmacovigilance centre (PvC)

    B Which approach to pharmacovigilance?

    Spontaneous reporting
    Targeted spontaneous reporting (TSR)
    Active surveillance

    C Spontaneous reporting

    Introduction
    Objectives and methodology
    Minimum reporting requirements
    How to report
    What to report
    When to report
    Who should report
    Follow-up
    Sharing the results
    Data entry

    D Targeted spontaneous reporting (TSR)

    Introduction
    Objectives and methodology
    A PRACTICAL HANDBOOK ON THE PHARMACOVIGILANCE OF MEDICINES USED IN THE TREATMENT OF TUBERCULOSIS
    E Cohort event monitoring (CEM)
    Introduction
    Objectives and methodology
    Implementation
    Establishing the cohort(s)
    Acquiring the data
    Database for CEM
    Maximizing the reporting rate
    Practical advice and information
    Clinical review

    F Data processing

    G Relationship and causality assessment

    Background
    Relationship (“objective phase”)
    Categories of relationship
    Processes for establishing the relationship
    Causality (“subjective phase”)

    H Special types of event

    Serious events
    Pregnancy
    Lactation exposure
    Deaths
    Lack of efficacy
    Late onset reactions
    Co-morbid conditions

    I Signal identification

    Introduction
    Selection criteria for events to investigate
    Methods of signal identification

    J Evaluating a signal

    General approach
    Other experience
    Searching for non-random patterns
    Comparison with control events
    Pharmacology
    Undertaking epidemiological studies
    Communication and feedback

    K Identifying risk factors

    Introduction
    Identification

    L Data description and analysis

    M Organization

    Legislation
    Ethical issues
    Structure
    Communication

    Certificate Code

    Contact Us

    Great Online Training
    C/o S V Residency,Flat No"301,
    Plot No:528&531B,Ramnagar,
    SVRC0528, Kondapur, Hyderabad, Telangana 500084
    E mail : support@greatonlinetraining.com
    India : +91-9966956770
    USA : +1 (551) 226-6061
    Skype : greatonlinetrainer
    Whatsapp : +91-9966956770
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