Spring Intro 2023

30/03/2023

Neil

What does regulatory add?

MAA

Phase 1 Phase 2 Phase 3

Post Approval

The Organisation for Professionals in Regulatory Affairs The Organisation for

Professionals i Regulatory Affairs

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What can an effective regulatory function add?

Regulatory affairs should facilitate the drug development process.

Effective regulatory strategies • The most feasible drug development path • Speed to market • Reputation and perception • Savings on time • Better allocation of resources • ‘Low maintenance’ documentation • Safety focused and commercially focused life cycle opportunities

Strategic Regulatory Leadership

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