CRED SMPC 2024

17/09/2024

Learning Objectives

To understand time points in the drug development timeline to consider label and leaflet development To understand the specific requirements for labels and leaflets for Mutual recognition (MRP), Decentralised (DCP) and Centralised Procedures (CP)

To understand practical issues for consideration when preparing labels and leaflets

To understand the role of regulatory and other company departments in label and leaflet development

The Organisation for Professionals in Regulatory Affairs

3

Timelines

The Organisation for Professionals in Regulatory Affairs

4