Spring Intro 2023

30/03/2023

Neil

Think Global – Importance of a truly Global Regulatory Strategy

MAA

Phase 1 Phase 2 Phase 3

Post Approval

The Organisation for Professionals in Regulatory Affairs The Organisation for

Professionals i Regulatory Affairs

15

What ? • A Global Regulatory Filing Strategy that considers access to patients in as many regions as possible Why ? • Optimisation of development, subsequent regulatory filings, approvals in global markets AND patient access • Reduces time to approval and use of internal resources • Simultaneous submissions in key regions and potential use of “novel” filing routes i.e., US, EU, JPN, CAN, CH, GB, AUS, RUS, Asia • Planning and Development of a Global Regulatory Dossier • Minimise regulatory set-up and maintenance through the lifecycle When ? Top tip: PLAN EARLY – Many countries have additional data requirements and often regulatory are the driver for commercial prioritisation What, Why When?

The Organisation for Professionals in Regulatory Affairs

16