Fundamentals of International Regulatory Affairs
Section II: Pharmaceuticals
Chap 9 Premarket Requirements/Dossier Requirements
Chap 10 Authorization Procedures for Pharmaceutical Products
Chap 11 Stability Test Requirements
Chap 12 Quality Systems and Inspection Processes
Section IV Biologics
Chap 23 High-Risk Products: Products Derived from Biotechnology
Chap 24 Advancement of Biosimilars Development
Chap 25 Vaccines
The Challenge of CMC Regulatory Compliance for Biopharmaceuticals
1) Complexity of biologics and vaccine regulations
2) Challenge of adventitious agent control
3) Manufacturing processes for biologics and vaccines
4) Quality by design for manufacturing processes
5) Risk management for manufacturing processes
Grading: Midterm (50%), Final Exam (50%)