CRED Getting the CMC Dossier Right 2024

28/08/2024

Quality Overall Summary: Module 2.3

• Module 2 summaries are key documents for reviewers

• QOS has a combined function as both summary and an “Expert Report” in EU

• Discuss and critique critical key data

• Opportunity to explain any deviations from guidelines

The Organisation for Professionals in Regulatory Affairs

27

QOS vs Module 3.2.S

The Organisation for Professionals in Regulatory Affairs

28