The course “Rules of variations grouping” will help you to explore how to group variations based on the European guidance, what are specific rules for variation grouping and what we shall consider acceptable and unacceptable in terms of grouping. In addition, this course will allow you gain solid understanding about a worksharing procedure, which serves as a time saver and cuts down unnecessary work by both the MAH and competent authority.

The student after completing this course should be able to:

• Demonstrate knowledge about key regulations and guidance related to variation grouping
• Know rules for proper grouping of variations for medicinal products
• Present both acceptable and not-acceptable grouping of variations
• Understand the worksharing procedure (for multiple marketing authorisations); demonstrate knowledge regarding the procedural steps; explain why worksharing is a beneficial procedure and explain pre-submission activities