CRED SMPC 2024

18/09/2024

CRED Overview of Product Information - 25 September 2024

Case Study and feedback – Label and Leaflet

Gabriela Fok, Senior Regulatory Affairs Manager at Ipsen Thomas Liebers, Senior Director, Global Labeling, ICON plc

The Organisation for Professionals in Regulatory Affairs

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Objective of this session

Through a practical exercise, to get a flavor of some of the interdependencies of the desired Label and Leaflet text (Innovator), Health Authority requirements and applicable guidance (QRD template, EU guidelines) and other technical aspects of Package engineering.

Through discussion of the examples in the case study, to achieve a deeper understanding and learning result. To discuss wider implications of the Label and Leaflet development in the broader context of the R&D setting.

Forum for Questions and Answers.

The Organisation for Professionals in Regulatory Affairs

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