CRED SMPC 2024

17/09/2024

CRED Regulatory Product Information

Strategy for the Development of the Optimal Summary of Product Characteristics (SmPC)

25 th September 2024

Khristy Horsley and Lucy Paterson Global Labelling Strategists

ENABLING AND PROMOTING EXCELLENCE IN THE HEALTHCARE REGULATORY PROFESSION

The Organisation for Professionals in Regulatory Affairs

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Learning outcomes

• Definition of an optimal SmPC and its purpose (the “what” and the “why”) • Developing the SmPC within the development programme (The “when”) • Key Stakeholders in developing an SmPC (The “who”)

• How do you develop a good SmPC ? (The “how”)

• … and the “where” …

The Organisation for Professionals in Regulatory Affairs

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