Filing variations is a major component of regulatory lifecycle management. It is important to optimise your procedures for faster, streamlined and compliant variation submissions. Regulators want to see successful variations strategies across regulatory teams. It is therefore important for you to understand the regulations, definitions and best practice for implementation.
This training course will provide you with a complete overview of the EU regulations when filing a variation to marketing authorisation. You examine the various types of variation and learn how to optimise your procedures for streamlined variation submissions. You will also examine grouping and worksharing so you know when to apply it to your variations
With the Educo Post Learning Implementation Plan (PLIP) you will have the framework to apply and implement the knowledge acquired in the training, supporting you in your development. Learn more about how we deliver live online training.