Module 3 Presentations

07/05/2024

Learning Outcomes

What are regulatory requirements for Pharmaceutical Packaging? How to reflect the requirements in the dossier? How to differentiate Pharmaceutical Packaging from Devices? What to consider for Drug-Device combinations?

The Organisation for Professionals in Regulatory Affairs

3

In this presentation we will cover

What does “packaging” mean? / Definitions What are requirements for pharmaceutical packaging? • Proof of Quality • Proof of Suitability

Specifications and other documentation Specifics on Drug-Device combinations

The Organisation for Professionals in Regulatory Affairs

4