Ep 18 Recap: Embracing Validation 4.0 for a Digital Pharma Future

Ep 18 AI in Pharma Compilation Part 2

n this episode, listen to highlights from our most recent Artificial Intelligence-focused episodes, featuring discussions with speakers from the FDA, Sanofi, and the Open BioPharma Research and Training Institute on the potential for AI to reshape the drug lifecycle, how companies are leveraging artificial intelligence to drive quality transformation and accelerate workforce readiness, and more.

Ep 18 Recap: Embracing Validation 4.0 for a Digital Pharma Future

In this recap episode, Michelle Vuolo, Head of Quality at Tulip Interfaces and ISPE Good Practice Guide: Validation 4.0 co-lead, along with guide team member, Victor de Oliveira Silva Ferreira, Cruz, Project Manager for PEQMS – Implementation of Electronic Systems for the Quality Management System, Instituto De Tecnologia Em Imunobiológico/Fundação Oswaldo Cruz, join the podcast share their insights on how Validation 4.0 aims to leverage digital tools to transition from traditional validation methods to more dynamic, real-time processes.

Ep 17 AI in Quality Transformation

In this episode, Miguelina Matthews, Head of Quality Intelligence, Advocacy and Pharmacopoeia Affairs at Sanofi, joins the podcast to share how the company is leveraging artificial intelligence to shift pharmaceutical quality management from reactive investigations to predictive, data-driven insights. Learn more about the deployment of Sanofi's "Plai" tool, emphasizing the importance of robust governance, effective change management, and human-led decision-making in scaling AI technologies across global operations.

Ep 16 Insights from the 2026 ISPE Europe Annual Conference Committee Chair

On this episode, David Estapé, Technology Manager Biotechnology at CRB Group GmbH, and International Program Committee Chair of the 2026 ISPE Europe Annual Conference, joins the podcast to discuss the upcoming conference and the topics, speakers, and key highlights of what you can expect from the educational content and agenda.

Ep 15 Integration of Artificial Intelligence in the Pharmaceutical Industry: A US FDA Perspective

This episode features insights from Tina Kiang, PhD, Director of the Division of Regulations and Guidance in the Office of Pharmaceutical Quality (OPQ)/Office of Policy for Pharmaceutical Quality (OPPQ) at the US Food and Drug Administration (US FDA). In a discussion facilitated by David Churchward, Head of Operations Quality Compliance and External Affairs at AstraZeneca, Kiang examines AI at the intersection of regulatory guidance and pharmaceutical innovation, sharing how AI has the potential to reshape the drug lifecycle, the US FDA’s current posture and guidance trajectory, how US FDA is currently using AI, and more.