This course is designed to provide participants with an understanding of the new quality guidelines issued by the International Council for Harmonisation (ICH) and the European Medicines Agency (EMA). The course will cover the latest updates on ICH Q3D, Q12, and Q13 guidelines, as well as EMA Q&As on good manufacturing practice (GMP) and good clinical practice (GCP). Participants will learn about the practical implications of these guidelines and how to ensure compliance with them.