स्वास्थ्य और परिवार कल्याण मंत्रालय
वापस
National Institute of Health and Family Welfare (NIHFW)
7th RTP on Evaluation of Clinical and CMC Data of New Drugs, Vaccines and Recombinant Products
अभी नामांकन करें
4 नामांकित विद्यार्थी
पाठ्यक्रम के बारे में
कैरियर प्रमाणपत्र प्राप्त करें
कोई प्रशिक्षक नहीं
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Overview of Clinincal Trial- Regulations, Phases of Clinical trials including approval process
PDF
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Review and interpretation of animal and pharmacology, toxicology data
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Various committees and their Role in New Drug Approval Porcess
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Clinical Trial Design and Method of Reandomization
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Evaluation of Clinical Trial data of New Drug
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Evaluation of Clinincal Trial Data of Vaccines and rDNA
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Evaluation of CMC Data of New Drugs
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Evaluation of CMC for rDNA Vaccines
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Detection of Data Integrity and forensic evaluation of Electronic data
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Developement of soft skills
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Role of Biostatistician in review of Clinical Trial protocol and report
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Requirements of Post approval changes for biological products
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Serious Adverse Effects (SAEs) in Clinical Trials and reporting Casuality assessment of SAEs & Compensation skills
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Pharmacovigilance in India
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Assessment
Post Assessment
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Certificate
Certificate
इस पाठ्यक्रम के लिए अभी तक कोई समीक्षा नहीं है।
इस पाठ्यक्रम को साझा करें
इस पाठ्यक्रम में शामिल है
