CRED SMPC 2024

17/09/2024

CCDS Process

● Need a defined process within the company for the preparation, review, approval, maintenance and implementation of CCDSs – SOP controlled process ● All appropriate staff should be trained on the process.

The Organisation for Professionals in Regulatory Affairs

11

CCDS Process Overview

Multi-Disciplinary Team Evaluates Safety & Efficacy Data and Develops Company Position

Proposes Revisions to CCDS

Formal Approval of CCDS

Communicate to stakeholders

Implementation of CCDS Revisions into National Labels

Monitoring of Compliance with CCDS

The Organisation for Professionals in Regulatory Affairs

12