Welcome to the 28th episode of Automating Quality. Mandy Gervasio is your host, and she’s on a mission to bring you hot industry topics with her fellow life sciences partners and friends!
Today’s episode is all about regulatory convergence! In the world of globalization, it makes sense that we’re finally starting to see extensive shifts in philosophy and regulations as they apply to the Life Sciences industry, which are setting new quality standards for drug and device manufacturers. It’s a very exciting topic as there have been some incredibly notable changes in the last 5 years!
In this episode, Mandy will be highlighting some of the key pieces to consider when thinking about the concept of regulatory convergence and explains how it is driving extensive shifts in the Life Sciences space.
[:28] About today’s episode.
[1:00] Mandy explains what the term ‘regulatory convergence’ refers to.
[2:38] What is the Mutual Recognition Agreement (MRA) and how is it related to the concept of regulatory convergence?
[5:22] Mandy highlights some of the key benefits impacting public health that stem from regulatory harmonization.
[8:25] Mandy speaks about the two major international standard bodies that are playing a vital role in regulatory harmonization (or convergence) and highlights the technical areas that they are affecting.
[12:59] Mandy wraps up this week’s episode and thanks listeners for tuning in!
Mentioned in this Episode:
World Health Organization (WHO)
The International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH)