About the Course
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Evaluation of Clinical and CMC of New Drugs, Vaccine and Recombinant products and Biostatistics
Overview of Clinincal Trial- Regulations, Phases of Clinical trials including
Review and interpretation of animal and pharmacology, toxicology data
Various committees and their Role in New Drug Approval
Clinical Trial Design and Method of Reandomization
Evaluation of CT data of New Drug
Evaluation of Clinincal Trial Data of Vaccines and rDNA
Evaluation of CMC Data of New Drugs
Evaluation of CMC for rDNA Vaccines
Detection of Data Integrity and forensiv evaluation of Eletonic data
Developement of soft skills
Role of Biostatistician in review of Clinical Trial protocol and report
Requirements of Post approval changes for biological products
Serious Adverse Effects (SAEs)
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Certificate
Certificate
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