Рет қаралды 7,785
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