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.
- ◎ 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.
|PART III: Non-Clinical Assessment: Safety and Immunogenicity|
HD / Low
|Subject 1) Non-clinical ICH S6|
|1-1 Non-clinical ICH S6 (Non-clinical evaluation of biotechnology products)||View More42m 57s|
|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||View More|
|3-2 Perspectives on Immunogenicity and Acceptance of Foreign Clinical Data||28m 13s||View More|