BPCI CMC Regulatory Affairs Training 15th to 16th September 2022
The CMC Regulatory Affairs Training covers the key US and EU legislation and regulatory systems for drug and biologic approval and submission of changes. Some topics that are of current interest (shortages, batch specific requests) will also be covered. An FAQ section is included so that participants can ask questions related to something they are working on and benefit from the expertise of speakers and other participants.
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.
The Agenda for this Training is available here.