Module 3 Presentations

14/05/2024

A Regulatory Agency’s Perspective: Module 3 for a New Active Substance

Anargyros Foivas Pharmaceutical Assessor, HQA, MHRA 17 May 2024

The Organisation for Professionals in Regulatory Affairs

1

Learning Outcomes

Principles of assessment & the role of the Regulator Common deficiencies in module 3 Working with Regulators - how to minimise delays to approval stemming from module 3

The Organisation for Professionals in Regulatory Affairs

2

1