Spring Intro 2023

30/03/2023

Learning outcomes

Understand Regulatory Strategic Aspects of Following Topics:

• Initial Considerations + setting the framework • Understand the bigger picture and strategic thinking • IP and exclusivity considerations • Think Global • US, EU, beyond EU (GB post Brexit) and key considerations for Worldwide Markets • Regulatory/HTA Advice • Paediatric Development & PIPs • Orphan disease considerations • Early Access • Tradename

The Organisation for Professionals in Regulatory Affairs

101

Neil

What does the future hold ?

… Change!

MAA

Phase 1 Phase 2 Phase 3

Post Approval

The Organisation for Professionals in Regulatory Affairs The Organisation for

Professionals i Regulatory Affairs

102