Spring Intro 2023

03/03/2023

Module 3: An Agency Perspective TOPRA - An Introduction to Regulatory Affairs

Mirza Ćatibušić, Senior Pharmaceutical Assessor, HPRA

28 th March 2023

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Learning objectives

• Where to find information? • How and what to submit? • Introduction

• Understand the most common deficiencies identified during assessment of the DS and DP sections of MAAs • Brief overview of QbD / PAT • What do regulators expect to see in Module 3?

03/03/2023

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