CRED 8 Presentations

01/07/2024

Other Key Strategic Considerations UK

Similar to EU • Orphan drug considerations • Paediatric investigation plans (PIPs) • Scientific advice

Different to EU • Innovative Licensing and Access Pathway (ILAP) • Bridging the P3 to launch gap with early access • Promising Innovative Medicines designation (PIM) • Early Access to Medicines Scheme (EAMS) • Project Optimus / Access Consortium

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The Organisation for Professionals in Regulatory Affairs

39

SUMMARY

The Organisation for Professionals in Regulatory Affairs

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