Pharma Conversations Podcast

In this episode of Pharma Conversations Podcast, Kevin O’Donnell (HPRA) explains how QRM needs to move beyond tick‑box exercises to become truly knowledge‑driven and evidence‑based. He walks through the main changes in ICH Q9(R1) and what regulators expect from companies in practice. We discuss culture, misuse of RPNs and the idea of a “living” QRM system under continuous improvement. Kevin also shares how these principles apply to emerging areas like ATMPs, digitalisation and AI.Contact us at: Pharmaconversationspodcast@gmail.comThis episode is sponsored by Ecolab.

In this episode of Pharma Conversations, we’re joined by Patrick Nieuwenhuizen, a global leader in pharmaceutical quality, compliance, and sterility assurance with more than 30 years of experience across sterile manufacturing, biologics, and advanced therapies. Together, we explore the realities of unannounced FDA inspections, the shift toward permanent inspection readiness, and the cultural, operational, and knowledge‑management foundations needed to withstand modern regulatory scrutiny. Contact us at: Pharmaconversationspodcast@gmail.comThis episode is sponsored by Ecolab.

In this episode of Pharma Conversations, we’re joined by Kevin O’Donnell, Market Compliance Manager and Senior GMP Inspector at the HPRA, to discuss what good inspection readiness looks like from a regulator’s perspective. Kevin shares common inspection gaps, how organisations can build continuous readiness, and insights on data integrity, people preparedness, and outsourced activities. He also reflects on his experience working in Japan, exploring its culture of quality and lessons for the Irish and European pharma industry.Contact us at: Pharmaconversationspodcast@gmail.comThis episode is sponsored by Ecolab.

Matt Moran breaks down the challenges shaping the pharmaceutical industry from supply‑chain fragility and increasing regulatory complexity to the urgent need for sustainability and skilled talent. He highlights why the industry must modernise manufacturing, embrace digitalisation, and build greater resilience to stay competitive in a rapidly shifting global landscape.Matt is a prominent Irish biopharmaceutical industry expert, consultant, and former Director of BioPharmaChem Ireland (part of IBEC), where he spent three decades shaping Ireland's reputation as a global life sciences hub. He is currently an independent consultant, a board member of industry groups, and acts as a judge for industry awards. He is also Chair of the ARC Hub for Therapeutics Governance Committee.  Contact us at: Pharmaconversationspodcast@gmail.comThis episode is sponsored by Ecolab.