CRED Managing Variations Effectively

Introduction to Classification of CMC (Quality)/Clinical/PhV Variations

Life Cycle Management – Variations TOPRA CRED Variations, 7 th June 2018

Presented by Alberto Ganan Jimenez (Head of Evaluation Procedures Service D) & Jaime Oliva (Procedure Manager Service B) European Medicines Agency (EMA)

An agency of the European Union