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Evaluation of Clinical and CMC of New Drugs, Vaccine and Recombinant products and Biostatistics

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Evaluation of Clinical and CMC of New Drugs, Vaccine and Recombinant products and Biostatistics

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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)

  • Certificate

    Certificate

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This course includes

  • Video
  • Learning Content
  • Assessment
  • Discussion Forum
  • Feedback

For technical (platform) related queries, contact:

Nodal Officer, SAKSHAM
Dr. Dharmendra Kumar Yadav
Contact - +91-11-26165959 & +91-11-26107773 Ext.- 225

Assistant Nodal Officer, SAKSHAM
Dr. Raj Narayan
Contact - +91-11-26165959 & +91-11-26107773 Ext.- 327
Email - support.saksham@nihfw.org

Department of Statistics & Demography (S&D) NIHFW, New Delhi - 110067
Website : www.nihfw.org

For NMCN related queries, contact:

Dr. Avdesh Chandra
Project Consultant, National Resource Centre, National Medical College Network, AIIMS, New Delhi - 110608
Contact - +91-9910675076, +91-9818664747
Email - nrcsetfacility@aiims.edu