Variations are an essential part of pharmaceutical products lifecycle and a critical milestone
for the management of post-approval changes. Regulation worldwide is not yet harmonised
and this course will help you understand the specific legal framework of variations in Europe.
Through practical examples and exercices, you will learn to define the best submission strategy,
evaluate the documents to prepare and understand the challenges of implementing changes.
• Have a clear view of the European legislation on variations
• Understand the differences between change categories (Type IA, IB, II)
• Learn how to assess the impact of a change on the CTD dossier
• Understand the content of a variation dossier
• Learn how to define the best strategy for submitting a variation
• Work on the EU variation guideline through case studies
• Understand challenges for lifecycle and the impact of ICH Q12
• Introduction to the specificities of the Centralised Procedure