CRED SMPC 2024

17/09/2024

CRED Regulatory Product Information

Preparation of the Label and Leaflet: Industry Perspective

25 th September 2024

Robert Hetherington Associate Director, Global Labelling, Kyowa Kirin

ENABLING AND PROMOTING EXCELLENCE IN THE HEALTHCARE REGULATORY PROFESSION

The Organisation for Professionals in Regulatory Affairs

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Welcome and Introduction

Robert Hetherington, Associate Director Global Labelling, Kyowa Kirin

• BSc Pharmacology, MSc Toxicology

• Over 10 years in Regulatory Affairs, specifically in Labelling

• Currently work in Rare Diseases

• 4 years with generic medicinal products within Europe, 6 years supporting an Innovator client with CCDSs and regional labelling across different therapeutic areas

• Experience in Labelling strategy, Labelling Operations, Labelling Compliance

The Organisation for Professionals in Regulatory Affairs

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