CRED SMPC 2024

18/09/2024

Objective of this session

Through a practical exercise, to get a flavor of some of the interdependencies of the desired SmPC text (Innovator), Health Authority requirements and applicable guidance (QRD template, EU guidelines).

Through discussion of the examples in the case study, achieve a deeper understanding and learning result.

To discuss wider implications of the SmPC development in the broader context of the R&D setting.

Forum for Questions and Answers.

The Organisation for Professionals in Regulatory Affairs

3

Format

Group discussion

The Organisation for Professionals in Regulatory Affairs

4