Across three days, this track offers fresh perspectives and practical insights on emerging regulatory frameworks, inspection reliance, AI governance, lifecycle validation, and the future of pharmaceutical quality systems. With rich representation from industry, academia, and health authorities, the sessions reflect a shared commitment to advancing regulatory science in a way that strengthens trust, safeguards patients, and supports innovation.
Day 1: Foundations of Quality Systems and Mindset Shifts
The track opens on Monday, 20 April, with a set of sessions that explore foundational components of quality management and their role in strengthening compliance.
Alex Mbonye of Uganda’s National Drug Authority brings a regulator’s perspective on the criticality of embedding robust QMS at the heart of regulatory operations. Drawing from his extensive experience implementing QMS frameworks in laboratory and inspection settings, in this session, he illustrates how structured systems drive consistency, science-based decisionmaking, and regulatory maturity—especially within resource-constrained environments.
Jessica Helbling, University of St. Gallen, presents findings from more than 60 industry interviews in this session, highlighting a persistent tension between compliancedriven and improvementdriven cultures. Her research provides pragmatic pathways for organizations seeking to harmonize both mindsets, demonstrating that quality excellence emerges when regulatory rigor and continuous improvement reinforce rather than restrict each other.
In this session, Karim Kacimi of Novo Nordisk provides insight into how structured variations, postapproval change management protocols (PACMPs), and contemporary ICH guidelines are reshaping regulatory strategy. With increasingly complex global product portfolios, his perspective underscores the importance of harmonized approaches that streamline lifecycle management while sustaining patient safety.
Day 2: Regulatory Innovation, Collaboration, and Global Harmonization
On Tuesday, 21 April, the program advances into forwardlooking topics that reflect both the challenges and the opportunities of a fastchanging global regulatory ecosystem.
This session highlights how regulators are enabling efficient development pathways while upholding patient protection. Attendees can expect discussions around modernization initiatives, faster scientific communication, and approaches that support emerging modalities without compromising on GMP fundamentals.
Nina Cauchon, PhD, of Amgen presents on the role of cloudenabled regulatory collaboration in accelerating dossier development, managing global submissions, and improving data lifecycle integrity. As organizations adopt modern digital ecosystems, her insight clarifies how technology can enhance—not complicate—regulatory compliance.
A standout innovation presented by Geert Vandenbossche, PhD, this session showcases a breakthrough in aseptic technology: a steamsterilized isolator designed to comply with Annex 1 requirements for indirect product contact items. The qualification of this system represents a step forward in contamination control, bridging isolator technology with the highest sterility assurance standards. The presentation offers a rare inside look at the engineering, qualification approach, and regulatory considerations behind an emerging industry milestone.
Day 3: Digital Transformation, Structured Submissions, and the Dossier of the Future
The final day, Wednesday, 22 April, turns toward digital regulatory innovation, datadriven oversight, and the future of chemistry, manufacturing, and controls (CMC) submissions.
Monica Perea-Vélez of GSK explores how digitalization, data standards, and structured content are reshaping the regulatory dossier. As agencies increasingly adopt cloudsupported review models, companies must evolve their submission strategies to align with new expectations for transparency, data reusability, and realtime updating.
A panel featuring Ciby Abraham (AstraZeneca), Rodrigo Palacios (Roche), and Vada Perkins (Boehringer Ingelheim) examines new frontiers in structured submissions, including AIenabled content automation, digital regulatory intelligence, and collaborative review environments. Together, they provide a candid look at the practical and strategic considerations surrounding the next generation of global regulatory submissions.
Closing the track, Stuart Finnie of Gilead Sciences delivers an indepth look at lifecycle management in a globalized regulatory environment. As companies expand into new markets and technologies evolve, structured, riskbased lifecycle strategies are more important than ever to managing product robustness and uninterrupted patient access.
A Track Shaped by Collaboration and Forward Momentum
The Regulatory and Quality track at the 2026 ISPE Europe Annual Conference reflects an industry in active transition—toward digital ecosystems, modern regulatory frameworks, harmonized inspection models, and more resilient pharmaceutical quality systems. The sessions across the threeday program emphasize not just compliance, but collaboration, transparency, and continuous improvement.
By bringing together regulators, quality leaders, engineers, policy experts, and emerging professionals, the track provides a platform to collectively interpret regulatory evolution and shape its practical implementation.
For attendees responsible for regulatory affairs, quality systems, inspection readiness, product lifecycle management, or pharma digital transformation, this track offers a unique opportunity: to learn from global leaders, challenge conventional thinking, and help drive the future state of pharmaceutical regulation.
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