CRED ERP 25

01/07/2025

Timing – external environmental impact

• Competitors (“gold - standard”, orphan etc)

Medical need • Accelerated review/conditional approval

•

• Legislative Framework and changes in requirements • Keep up to date with the potential impact of the EU Pharmaceutical Legislation

Regulatory Agencies • Resources, holidays • Benchmarking on review timelines

•

The Organisation for Professionals in Regulatory Affairs

31

CONDITIONAL APPROVALS & EXCEPTIONAL CIRCUMSTANCE

The Organisation for Professionals in Regulatory Affairs

32

16