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National Institute of Health and Family Welfare (NIHFW) 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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7th RTP on Evaluation of Clinical and CMC Data of New Drugs, Vaccines and Recombinant Products

About the Course

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  • Overview of Clinincal Trial- Regulations, Phases of Clinical trials include

    PDF

  • Review and interpretation of animal and pharmacology, toxicology data

    PDF

  • Various committees and their Role in New Drug Approval

    PDF

  • Clinical Trial Design and Method of Reandomization

    PDF

  • Evaluation of CT data of New Drug

    PDF

  • Evaluation of Clinincal Trial Data of Vaccines and rDNA

    PDF

  • Evaluation of CMC Data of New Drugs

    PDF

  • Evaluation of CMC for rDNA Vaccines

    PDF

  • Detection of Data Integrity and forensiv evaluation of Eletonic data

    PDF

  • Developement of soft skills

    PDF

  • Role of Biostatistician in review of Clinical Trial protocol and report

    PDF

  • Requirements of Post approval changes for biological products

    PDF

  • Serious Adverse Effects (SAEs) in Clinical Trials and reporting Casuality

    PDF

  • Five Key Concepts PV - CDSCO TRAINING

    PDF

  • Assessment

    Post Assessment

  • Certificate

    Certificate

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This course includes

  • PDF
  • Assessment
  • Certificate
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For technical (platform) related queries, contact:

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

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