Variations in Europe - Your regulatory and procedural guidance

This seminar will bring you the latest in the
planning, classification and submission of
variations.

Day 1 addresses regulatory requirements
in detail, particularly guidance documents,
variation classification, use of the variation
(e-)application form and organisation of
grouping and work sharing.

Day 2 addresses the classification and
handling of quality-related changes. Case
studies on how to work with the classification
guideline and the Q+A paper will
reinforce your knowledge.