Advanced Module 3 Content for Biologics & Biosimilars

Course Agenda

Module1
• Understanding the Key aspects of the CTD Global Dossier & How to Think for Biological Medicines
Module 2
• Structure and Content of the CMC Sections of The CTD and Introduction to Drug Substance Sections
• CMC Expectations for Monoclonal antibodies –From Concept to reality
• CMC expectations for peptides
• CMC for Oligonucleotides
• Examples of sections
Module 3 –Session 1
• Understanding the Reviewers Perspective –The CTD Equation and Importance of Development Pharmaceutics
• Typical Questions
Module 3 –Session 2
• Understanding the Reviewers Perspective –The CTD Equation and Importance of Development Pharmaceutics continued

Module4 –Session 1
• Overview of Drug Product Sections of the Dossier
• Aseptic Manufacture
• Examples of data sets for CTD
Module4 –Session 2
• Overview of Drug Product Sections of the Dossier
• Critical Analysis
Module 5
• Understanding Source Documents –Reviewers Perspectives (Using Analytical for mAbexamples)
Module 6
• Global Dossier and Importance of Dossier Redaction