EU Variation Overview Regulatory Lectures by Rajashri Ojha at Raaj Pharmaelearning

Brief recap on registration of Pharmaceutical Products in Europe

Introduction of Product Life Cycle Management of Pharmaceutical Products in Europe

EU Variation Applications
Concept of “Variation” to the terms of Marketing Authorization

Variation classification guideline for European Union

Types of Variations

Definitions each type of variation,
fundamental concept & examples

Documentation required for variation filling

Grouping of variations

Timelines of variations

EU Renewal Applications
Concept of “Renewal “ to the terms of Marketing Authorisation
Renewal submission timelines
Documentation required for Renewal filling

Takeaway message to people working for Product Life Cycle Management of Pharmaceutical Products