MEB 317B
Chemistry, Manufacturing, and Controls Regulation of Pharmaceuticals

This course will provide an introduction to the concepts and requirements for global pharmaceutical regulatory Requirements. Chemistry Manufacturing and Controls (CMC) concepts as it relates to the manufacture of pharmaceutical products will be discussed in the course. Various regulations (FDA, ICH) that govern production of Pharmaceutical products will be addressed. Biological License Application (BLA) process for biological and plasma derivatives process will be discussed. This course provides a foundational knowledge for the registration process of Biopharmaceuticals.

• ICH/FDA Guidelines
• Principles and regulatory requirements for Approval
• Scientific principles and regulatory requirements for establishing product specifications
• Plasma Derivatives
• Pharmacovigilance/Complaints
• Biosimilar – Regulatory Considerations
• Orphan Drugs – Regulatory Considerations