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    PV + CDM

    Uploaded by

    dr.gopinathlakshmipathy
    Pharmacovigilance

    Copyright:

    © All Rights Reserved
    Download as PDF, TXT or read online from Scribd

    PV + CDM

    Uploaded by

    dr.gopinathlakshmipathy
    6 views1 page
    Pharmacovigilance

    Copyright

    © © All Rights Reserved

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    PDF, TXT or read online from Scribd

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    Pharmacovigilance

    Copyright:

    © All Rights Reserved
    Download as PDF, TXT or read online from Scribd
    Download as pdf or txt
    6 views1 page

    PV + CDM

    Uploaded by

    dr.gopinathlakshmipathy
    Pharmacovigilance

    Copyright:

    © All Rights Reserved
    Download as PDF, TXT or read online from Scribd
    Download as pdf or txt
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    Gopinath lakshmipathy

    2024

    HOW PHARMACOVIGILANCE AND CLINICAL


    DATA MANAGEMENT TEAM ARE INTERLINKED
    Pharmacovigilance and clinical data
    management (CDM) teams are closely
    interlinked in ensuring the safety and
    efficacy of pharmaceutical products
    throughout their lifecycle. Here's how
    they are connected:

    1. Data Flow: CDM teams collect and


    manage clinical trial data,
    including information on adverse
    events and patient outcomes.
    Pharmacovigilance teams rely on
    this data to identify and evaluate
    safety signals associated with the 4. Regulatory Reporting: Both
    use of a drug. teams collaborate to ensure timely
    2. Adverse Event Reporting: and accurate reporting of safety
    Pharmacovigilance teams receive information to regulatory
    adverse event reports from various authorities. CDM teams provide
    sources, including clinical trials. clinical trial data for periodic safety
    These reports contain data reports and other regulatory
    managed by CDM teams, such as submissions required by health
    patient demographics, medical authorities.
    history, and treatment details.
    3. Signal Detection: 5. Data Quality and Integrity: CDM
    Pharmacovigilance teams analyze teams ensure the quality and
    safety data to detect potential integrity of clinical trial data
    signals of new or known adverse through rigorous data management
    events. They may identify trends or processes. This high-quality data is
    patterns in the data that require essential for pharmacovigilance
    further investigation. CDM teams activities, such as signal detection
    provide the necessary clinical data and risk assessment.
    for this analysis.
    4. Safety Monitoring: Overall, effective communication
    Pharmacovigilance teams and collaboration between
    continuously monitor the safety pharmacovigilance and CDM teams
    profile of marketed drugs. They are essential to identify, assess,
    may request additional data from and manage safety concerns
    ongoing or completed clinical trials associated with pharmaceutical
    managed by CDM teams to assess products throughout their lifecycle.
    the long-term safety of a product.

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