Global Regulatory and Legal Requirements of Quality

Catalog description

This course, as part of the Quality Science Education curriculum developed by Pathway for Patient Health, will give students an understanding of the role of regulators with an overview of regulations as stated in the U.S. Code of Federal Regulations (CFR), EudraLex Directives and Annexes, and Emerging Market regulations for the life science industries. The course will demonstrate the relationship between regulatory requirements and legal accountability while introducing fundamental concepts in the regulations related to clinical trial development, management, ethics, data integrity, data security, privacy, change control, and validation. Topics such as the role of guidance documents and industry standards will be reviewed, and case studies utilized to support the program. The “why” of the regulations will support the student’s ability to enter the life science industry with an understanding of how to optimize patient health and business success by mobilizing enterprise-wide quality effectiveness through innovative systems and critical thinking grounded in science, data, stakeholder awareness and regulatory intelligence.