CRED SMPC 2024

17/09/2024

CRED Development of Regulatory Product Information in Europe

25 September 2024

Introduction

Petrina Pearce, Senior Manager Regulatory Affairs New Products,

Advanz Pharma

The Organisation for Professionals in Regulatory Affairs

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Learning Outcomes for Today

⚫ The Company Core Data Sheet, including origins and purpose

⚫ The role of the SmPC and how to produce the optimal SmPC

⚫ Current SmPC issues and developments including common pitfalls

⚫ Overview of SmPC and labelling legislation, guidelines and QRD template

⚫ Practical advice on compliance with the legislation

The Organisation for Professionals in Regulatory Affairs

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