Quality Assurance in Drug Development

This lecture covers the regulatory environment for quality compliance in drug development, focusing on the role of quality and compliance in ensuring the safety, efficacy, and quality of pharmaceutical products. It discusses the main features of the European Quality Management System, including quality assurance, quality control, and good practices. The lecture also addresses the importance of documentation, the impact of health authorities inspections, and the elements of a pharmaceutical quality system. Emphasis is placed on the need for preventative measures, systematic activities, and the balance between efforts and costs in maintaining quality standards.