CRED 8 Presentations

01/07/2024

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