This is the 12th CMC Regulatory Affairs training course that BPCI have run in conjunction with Meg McCarty, Regulatory Pharma Ireland. We are indebted to the HPRA as well as our industry speakers for the significant time and input they have provided in the design of the programme. It will address some common mistakes that are made with change variations and give some valuable industry insights from people who are working on these submissions first hand. The key EU/US legislation ad regulatory systems for drug/biologic approval and change submission is also covered, along with some more advanced topics. This course is aimed for people who would like to update their regulatory affairs knowledge and for those who are interested in moving into the space.