Ministry of Health and Family Welfare
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National Institute of Health and Family Welfare (NIHFW)
7th RTP on Evaluation of Clinical and CMC Data of New Drugs, Vaccines and Recombinant Products
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4 Enroled Students
About the Course
Earn a career certificate
No Instructor(s)
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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
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