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    Best Pharmacovigilance Course in Pune

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    TechnoBridge

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    Mode

    Online

    Duration

    2 Months

    Fees

    ₹ 23000

    Quick Facts

    particular details
    Medium of instructions English
    Mode of learning Self study
    Mode of Delivery Video and Text Based

    Course and certificate fees

    Fees information
    ₹ 23,000
    certificate availability

    Yes

    certificate providing authority

    TechnoBridge

    The syllabus

    Introduction to Clinical Research

    • Introduction to Clinical Research
    • Terminologies in Clinical Research
    • Advantages of CR in India
    • Introduction to Clinical Research- Notes
    • Introduction to Clinical Research Quiz

    Good Clinical Practice (GCP)-ICH E6

    • History Development of International Regulations in Clinical Research
    • Good Clinical Practices
    • Ethics committee
    • Investigator Responsibilities
    • Sponsor Responsibilities
    • Protocol and Investigator Brochure
    • Essential Documents

    Drug Development Process

    • Overview of Drug Development
    • Clinical trial phases
    • BA/BE Studies
    • Drug Development Notes
    • Drug Development Quiz

    Safety Reporting

    • Adverse Event Reporting
    • Recording of Event
    • Medical Management of Adverse Events
    • Handling Death
    • Unblinding of Drug
    • Clinical Safety and Pharmacovigilance
    • E2A- Clinical Safety and Data Management
    • Media 436
    • Naranjo Assessment
    • Order and Formulate to Determine the Quantum
    • SAE Reporting
    • Safety Reporting- Quiz

    Pharmacovigilance

    • Overview of Pharmacovigilance
    • History of Pharmacovigilance
    • ADR Classifications
    • Introduction to Aggregate Reporting
    • AE_SAE Reporting Process

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