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  • Pharmacovigilance Online Training

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    Retorslernenlabs
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    Pharmacovigilance online training Pharmacovigilance Basic: Legal basis for safety coverage as well as a historical perspective Basic definitions and tools Pre- and Post-marketing: Basic variations Pre-Marketed AEs Post-Marketed AEs The Importance of Adverse Event coverage Suspected sudden Serious Adverse Reaction Sources of ADRs Causality Lack of effectiveness Expectedness Minimum Criteria for coverage Expedited coverage An introduction to the Eudravigilance system Qualified Person for Pharmacovigilance (QPPV) needs Development Safety Update Reports European communication laws New EU Pharmacovigilance Legislation Pharmacovigilance Advanced: Types of Audits & Inspections Approaches Preparing for a Pharmacovigilance scrutiny Overview of the Pharmacovigilance Audit Best Practices Detailed Audit things Need for detection The Cost of Failure Signalling summary Regulatory needs Signal Detection Objectives Incidence, Numerator, divisor Need for the ready Mind Signal Detection Hierarchy Approach to detection Signalling Examples Risk assessment and management For more details: Hno 9-52/1 , road no: 3 New Dilshuknagar nagar colony Dilshuknagar,Hyderabad – 500072,India Mobi No:+91- 70326 71921 , Land line No: 040 60507020

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    Pharmacovigilance online training Pharmacovigilance Basic: Legal basis for safety coverage as well as a historical perspective Basic definitions and tools Pre- and Post-marketing: Basic variations Pre-Marketed AEs Post-Marketed AEs The Importance of Adverse Event coverage Suspected sudden Serious Adverse Reaction Sources of ADRs Causality Lack of effectiveness Expectedness Minimum Criteria for coverage Expedited coverage An introduction to the Eudravigilance system Qualified Person for Pharmacovigilance (QPPV) needs Development Safety Update Reports European communication laws New EU Pharmacovigilance Legislation Pharmacovigilance Advanced: Types of Audits & Inspections Approaches Preparing for a Pharmacovigilance scrutiny Overview of the Pharmacovigilance Audit Best Practices Detailed Audit things Need for detection The Cost of Failure Signalling summary Regulatory needs Signal Detection Objectives Incidence, Numerator, divisor Need for the ready Mind Signal Detection Hierarchy Approach to detection Signalling Examples Risk assessment and management For more details: Hno 9-52/1 , road no: 3 New Dilshuknagar nagar colony Dilshuknagar,Hyderabad – 500072,India Mobi No:+91- 70326 71921 , Land line No: 040 60507020

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    12 views2 pages

    Pharmacovigilance Online Training

    Uploaded by

    Retorslernenlabs
    Pharmacovigilance online training Pharmacovigilance Basic: Legal basis for safety coverage as well as a historical perspective Basic definitions and tools Pre- and Post-marketing: Basic variations Pre-Marketed AEs Post-Marketed AEs The Importance of Adverse Event coverage Suspected sudden Serious Adverse Reaction Sources of ADRs Causality Lack of effectiveness Expectedness Minimum Criteria for coverage Expedited coverage An introduction to the Eudravigilance system Qualified Person for Pharmacovigilance (QPPV) needs Development Safety Update Reports European communication laws New EU Pharmacovigilance Legislation Pharmacovigilance Advanced: Types of Audits & Inspections Approaches Preparing for a Pharmacovigilance scrutiny Overview of the Pharmacovigilance Audit Best Practices Detailed Audit things Need for detection The Cost of Failure Signalling summary Regulatory needs Signal Detection Objectives Incidence, Numerator, divisor Need for the ready Mind Signal Detection Hierarchy Approach to detection Signalling Examples Risk assessment and management For more details: Hno 9-52/1 , road no: 3 New Dilshuknagar nagar colony Dilshuknagar,Hyderabad – 500072,India Mobi No:+91- 70326 71921 , Land line No: 040 60507020

    Copyright:

    © All Rights Reserved
    Download as DOCX, PDF, TXT or read online from Scribd
    Flag for inappropriate content
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    Pharmacovigilance online training

    Pharmacovigilance Basic:

    Legal basis for safety coverage as well as a historical perspective


    Basic definitions and tools
    Pre- and Post-marketing: Basic variations
    Pre-Marketed AEs
    Post-Marketed AEs
    The Importance of Adverse Event coverage
    Suspected sudden Serious Adverse Reaction
    Sources of ADRs
    Causality
    Lack of effectiveness
    Expectedness
    Minimum Criteria for coverage
    Expedited coverage
    An introduction to the Eudravigilance system
    Qualified Person for Pharmacovigilance (QPPV) needs
    Development Safety Update Reports
    European communication laws
    New EU Pharmacovigilance Legislation

    Pharmacovigilance Advanced:

    Types of Audits & Inspections

    Approaches
    Preparing for a Pharmacovigilance scrutiny
    Overview of the Pharmacovigilance Audit
    Best Practices
    Detailed Audit things
    Need for detection
    The Cost of Failure
    Signalling summary
    Regulatory needs
    Signal Detection Objectives
    Incidence, Numerator, divisor
    Need for the ready Mind
    Signal Detection Hierarchy
    Approach to detection
    Signalling Examples
    Risk assessment and management

    For more details:


    Hno 9-52/1 , road no: 3
    New Dilshuknagar nagar colony
    Dilshuknagar,Hyderabad 500072,India
    Mobi No:+91- 70326 71921 , Land line No: 040 60507020

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