Spring Intro 2023

Lifecycle Management - Quality

TOPRA Spring Introductory Course 2023

Richard Keane, PhD, Regulatory CMC Biogen Idec Ltd, UK

The Organisation for Professionals in Regulatory Affairs The Organisation for

Professionals i Regulatory Affairs

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Agenda

 Definition of What is a Variation  EU Variations

● Legal Basis of Variations ● Classification of Variations ● Procedures and typical Quality examples  Submission Strategy ● Overview of grouping and worksharing  Global Perspective

The Organisation for Professionals in Regulatory Affairs

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