स्वास्थ्य और परिवार कल्याण मंत्रालय
वापस
National Institute of Health and Family Welfare (NIHFW)
4th RTP on Refersher Course on New Drugs and Clinical Trials Rules 2019
अभी नामांकन करें
3 नामांकित विद्यार्थी
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पाठ्यक्रम के बारे में
कैरियर प्रमाणपत्र प्राप्त करें
कोई प्रशिक्षक नहीं
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Overview of Clinical Trials - Regulations & Phases of Clinical Trial
PDF
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Clinical trial Design and method of randomization
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Evaluation of Clinical Trial Data and Role of Biostatistician
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Marketing Authorization Process of New Drugs, Investigational New Drugs, Fixed Dose Combination and Subsequent New Drugs
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IEC Registration & role of Ethics Committee
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Various Commitees and there roles in New Drugs Approval Process
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Emerging Issues in Clinincal Bioresearch Monitoring
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Evaluation of CMC data
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Clinical Data Evaluation for marketing authorization of new drugs
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Post-marketing surveillance and its monitoring
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Introduction to GCP, Conduct of GCP inspections and findings
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Pharmacovigilance programme in india
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Good Clinical Laboratory Practice
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Human Subject Protection Regulation & Identifying Bias in Clinical Trials
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Detection of Data Integrity and Forensic Evaluation of Electronic data
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SERIOUS ADVERSE EVENTS Clinical Trials and reporting Causality Assessment & Compensation
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Post Assessment
Assessment
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Certificate
CDSCO Certificate
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