Spring Intro 2023

30/03/2023

• What ? • A Global Regulatory Strategy to ensure access to patients and meeting commercial priorities • Why ? • Allows optimisation of development and regulatory filings leading to efficient approvals across global markets • Allows for simultaneous submissions in key regions • When ? • Early in development – many countries have additional data requirements • How ? • Define country and regional priorities and consider conserved filing routes • Additional data requirements – clinical studies, stability data, manufacturing plan • CPP availability • Where ?......Everywhere • Who ? • Internal and External Global Strategy Top Tips: Start planning early – Requirements Consider long term supply strategy and CPP availability

The Organisation for Professionals in Regulatory Affairs

27

David

Regulatory Advice

MAA

Phase 1 Phase 2 Phase 3

Post Approval

The Organisation for Professionals in Regulatory Affairs The Organisation for

Professionals i Regulatory Affairs

28