Tutorial 03: Update on Practical Work with Variation Regulation

The aim of this tutorial is to focus on identified challenges and how they can be solved by common/pragmatic solutions and interpretations agreed by the different stakeholders. Furthermore, the tutorial will give an outlook to the situation when the Variation Regulation will also apply to purely nationally authorised licences and how the regulation and the corresponding guidelines have been changed in order to comply with the new Pharmacovigilance legislation.

Regulatory affairs professionals from industry involved in the strategic preparation, compilation, organisation and management of variations in the EU for all procedures, Centralised Procedure (CP), Mutual Recognition Procedure (MRP), National Procedure (NP)

At the conclusion of this tutorial, participants will be able to:

• Operate variation applications adhering to all available guidance documents identify and categorise variations correctly
• Recognise advantages and pitfalls of the variation regulation
• Elaborate strategies for grouping and work sharing
• Explain the impact of the implementation of the variation regulation for purely national licenses and apply changes related to the new pharmacovigilance legislation