Queens of Quality Podcast

The Regulatory Landscape

Episode Notes

Welcome to another fantastic episode with your hosts, Jennifer and Michelleanne. In today’s episode, we talk about the regulatory landscape of the pharmaceutical industry. We focus on the role of regulatory organizations and the changes that have taken place in the regulatory process since the development of the polio vaccine.

Additionally, we talk about the relationship between quality and regulatory and the importance of leveraging your regulatory department. Finally, we discuss whether firm size affects regulatory requirements and how people can ensure that they have solutions that are fit for purpose.

Tune in!

During this episode, you will learn about;

[00:01] Episode introduction

[00:35] Today’s focus; Regulatory landscape

[02:21] What we took for granted pre- COVID-19

[04:10] Changes that have taken place in the regulatory process since the development of the polio vaccine

[08:39] What is the role of the regulatory organization

[12:39] Quality vs. Regulatory

[13:56] Why leveraging your regulatory department is important

[16:00] European Medicines Agency (EMA) regulatory guidelines

[18:22] Precision medicine (personalized medicine)

[23:13] Does firm size affect regulatory requirements?