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