Spring Intro 2023

16/02/2023

Abridged Applications and Generics

Andrew Modley, Senior Director – European Generic Registrations – Teva Pharmaceuticals Europe

The Organisation for Professionals in Regulatory Affairs

1

Learning Objectives

• Legal routes of abridged applications and supporting data requirements • Data exclusivity • Patents • Specifics of generic products

The Organisation for Professionals in Regulatory Affairs

2