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Refresher Course on New Drugs and Clinical Trials Rules 2019 13th to 17 th Marcch 2023
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Refresher Course on New Drugs and Clinical Trials Rules 2019 13th to 17 th Marcch 2023

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  • Refresher Course on New Drugs and Clinical Trials Rules 2019 13th to 17 th Marcch 2023

    Overview of Clinical Trials - Regulations & Phases of ct

    Clinical trial Design and method of randomization

    Evaluation of Clinical Trial Data and Role of Biostatistician

    Marketing Authorization Process of ND, IND, FDC and SND

    IEC Registration & role of Ethics Committee

    Emerging Issues in Clinincal Bioresearch Monitoring

    Evaluation of CMC data

    Post-marketing surveillance and its monitoring

    Introduction to GCP, Conduct of GCP inspections and findings

    Pharmacovigilance programme in India

    Good Clinical Practices

    SAE in Clinical Trials and reporting Causality

  • Certificate

    CDSCO Certificate

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  • Certificate
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