CRED Understanding Clinical Development 2024

14/10/2024

Other Considerations: US vs EU

US

EU

Advice procedures

EOP2 (Type B) meeting

Scientific Advice or Protocol Assistance (Orphan drugs) National Scientific Advice

• •

•

Special Protocol Assessment

•

Study Design

• Differences in clinical practice could result in differences e.g. in Choice/Dose of Comparator • HAs differing views on acceptability of endpoints (e.g. use of surrogate endpoints in Oncology; composite endpoint in AD)

Clinical Trial Approval

Written approval not required (can start 30 days after notifying FDA)

Written approval from individual countries where study running required. (EU CTR)

The Organisation for Professionals in Regulatory Affairs

26

26

Exercise

The Organisation for Professionals in Regulatory Affairs

27

27