Phar 651: Regulatory Science I
This course involves practical and theoretical principles involved in regulatory approvals of pharmaceutical products, and compliance requirements related to the development and manufacturing of pharmaceutical products. Emphasis is placed on Chemistry Manufacturing and Control (CMC) documents contained in regulatory submission packages and major FDA and ICH guidance documents applicable to product development, manufacturing, post-approval changes, and quality assurance. Guest lecturers with expertise in regulatory science will provide the students with the opportunity to discuss problems relevant to the industry. The course will require students to critically review and present publications in small groups and conduct other assignments.
- Lecture: Lecture for Phar 651