CRED SMPC 2024

First page Table of contents Next page Last page
Cover Page1
Course Programme2
Speaker Biographies4
Overview of the Day8
Lecture 1: The Company Core Data Sheet (CCDS)10
Lecture 2: The SmPC: Regulator’s Perspective20
Lecture 3: Strategy for the Development of the Optimal Summary of Product Characteristics (SmPC)45
Lecture 4: Labels and Leaflets: A Regulator’s Perspective74
Lecture 5: Preparation of the Label and Leaflet: Industry Perspective107
Lecture 6: Implementation of Labels and Leaflets: Industry Perspective120
Case Studies130
Case Study Session 1: SmPC130
Product Characteristics140
Case Study Sesson 2: Label and Leaflet145
Appendix151
Appendix II151
Appendix III153
Product Characteristics Annotated154

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