Module 9 2024

First page Table of contents Next page Last page
Cover Page1
Programme2
Lecture 1: Overview of Regulation of Biologicals6
Lecture 2: Preclinical Testing of Biologicals50
Lecture 3: Clinicals Development of Biopharmaceuticals66
Lecture 4: Immunogenicity Issues82
Lecture 5: Quality/CMC Considerations104
Lecture 6: Module 3 Guideline Requirements126
Lecture 7: Bioassays138
Regulation of Biosimilars168
Lecture 9: Regulation of Vaccines200
Lecture 10: Regulation of Gene and Cell Therapy Products248

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