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

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  • Refresher Course on New Drugs and Clinical Trials Rules 2019 13 to 17 March 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

    Dr Bhatt-CDSCO-ECRole-14Mar23

    Various Committees and there roles in New Drugs Approval Process

    Emerging Issues in Clinincal Bioresearch Monitoring

    Evaluation of CMC data

    Clinical Data Evaluation for marketing authorization of new drugs

    Post-marketing surveillance and its monitoring

    Introduction to GCP, Conduct of GCP inspections and findings

    Pharmacovigilance programme in India

    Detection of Data Integrity and Forensic Evaluation of Electronic data

  • Certificate

    Certificate

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  • Certificate
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