The holder of this certificate has attended the course "Understanding EU Regulatory Affairs".

This course will provide a clear understanding of the procedures involved in obtaining and maintaining market authorisations for medicines in the European Union. You will discuss the EU legislative framework and regulatory procedures for MAA submission. You will examine the regulations throughout the product life cycle, from product development and submissions to post market obligations. Once completed, you will have a solid awareness of the importance of regulatory affairs in your role and organisation.