CHE2500 — Global Quality Regulations
This course provides students an understanding of the role of regulators with an overview of global regulations as stated in the U.S. Code of Federal Regulations (CFR), EudraLex Directives and Annexes, and Emerging Market regulations for the pharmaceutical, medical device, biotech, animal health and consumer goods industries. Explores the relationship between regulatory requirements and legal accountability while introducing fundamental concepts in regulations related to clinical trial development, management, ethics, data integrity, data security, privacy, change control and validation. pre-req: