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Supply Chain Integrity (USP)

Biotherapeutics Online Course

This online course provides basic knowledge on essential elements of Biotherapeutics.
Each lecture was developed using training materials from previous AHC workshops & CoE Pilot trainings, and categorized into 5 Parts.



  • Course Guide:
    •   ◎    This online course provides trainings on Biotherapeutics in 5 Parts.
               Please click on each part to select topics of interest.
    •   ◎    Each lecture offers videos in two (2) different resolutions (HD/Low).
               Please select the version of your choice.
    •   ◎    Related guidelines (PDF) for each topic will be shown for your reference
               when you click the  button. Please click on each icon to view the file.
  • Video lecture
    PART III: Non-Clinical Assessment: Safety and Immunogenicity
    Title Video Lecture
    Low  /  HD
    Time Guideline
    Subject 1) Non-clinical ICH S6
    1-1 Non-clinical ICH S6 (Non-clinical evaluation of biotechnology products) 42m 57s
    Related Guideline
    Title Summary PDF
    Title Summary PDF
    ICH M3(R2) Guidance on Nonclinical Safety Studies for The Conduct of Human Clinical Trials and Marketing Authorization for Parmaceutical
    ICH S6(R1) Preclinical Safety Evaluation of Biotechnology-Dericed Pharmaceuticals
    ICH S9 Nonclinical Evaluation for Anticancer Pharmaceuticals
    Subject 2) The Importance of Immunogenicity Assessment
    2-1 The Importance of Immunogenicity Assessment of Therapeutic Proteins 27m 47s
    2-2 Considerations of Immunogenicity in Determining Biosimilar - With case studies 54m 48s
    Subject 3) Clinical, Safety, and Immunogenicity
              - Regulatory Harmonization and Convergence: Technical Consideration
    3-1 Overview and Current Status of APEC MRCT Roadmap - Connection to Biotherapeutics Roadmap 25m 26s
    Related Guideline
    Title Summary PDF
    ICH E5(R1) Ethnic Factors in the Acceptability of Foreign Clinical Data
    3-2 Perspectives on Immunogenicity and Acceptance of Foreign Clinical Data 28m 13s
    Related Guideline
    Title Summary PDF
    ICH E5(R1) Ethnic Factors in the Acceptability of Foreign Clinical Data