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National Institute of Health and Family Welfare (NIHFW) National Institute of Health and Family Welfare (NIHFW)

4th RTP on Refersher Course on New Drugs and Clinical Trials Rules 2019
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4th RTP on Refersher Course on New Drugs and Clinical Trials Rules 2019

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  • Overview of Clinical Trials - Regulations & Phases of ct

    PDF

  • Clinical trial Design and method of randomization

    PDF

  • Evaluation of Clinical Trial Data and Role of Biostatistician

    PDF

  • Marketing Authorization Process of ND, IND, FDC and SND

    PDF

  • IEC Registration & role of Ethics Committee

    PDF

  • Various Commitees and there roles in New Drugs Approval Process

    PDF

  • Emerging Issues in Clinincal Bioresearch Monitoring

    PDF

  • Evaluation of CMC data

    PDF

  • Clinical Data Evaluation for marketing authorization of new drugs

    PDF

  • Post-marketing surveillance and its monitoring

    PDF

  • Introduction to GCP, Conduct of GCP inspections and findings

    PDF

  • Pharmacovigilance programme in india

    PDF

  • Good Clinical Practices

    PDF

  • Human Subject Protection Regulation & Identifying Bias in Clinical Trials

    PDF

  • Detection of Data Integrity and Forensic Evaluation of Electronic data

    PDF

  • SAE in Clinical Trials and reporting Causality

    PDF

  • Post Assessment

    Assessment

  • Certificate

    CDSCO Certificate

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