Pharma & Biotech Quality Summit 2026

The Pharma & Biotech Quality Summit 2026, organised by Fleming Pharma and Biotech Events, will take place on 12–13 May in Munich, bringing together senior quality leaders from across Europe’s pharmaceutical and biotechnology sectors.

At a time of accelerating innovation and increasing regulatory scrutiny, the role of quality is undergoing a fundamental transformation. No longer confined to compliance oversight, quality functions are becoming strategic enablers of innovation, operational resilience, and patient safety. This year’s summit will explore how organisations are adapting to these shifts in a rapidly evolving regulatory and technological landscape.

From Compliance to Risk-Based Quality

A central theme of the summit is the industry’s transition from inspection-driven models to proactive, risk-based quality management. Organisations are increasingly embedding quality into day-to-day operations, supported by advanced analytics and artificial intelligence.

These tools are enabling earlier risk detection, improved decision-making, and stronger knowledge management within Pharmaceutical Quality Systems. However, they also introduce new regulatory challenges, particularly around validation, explainability, and lifecycle management in GxP environments, where industry practices are often advancing faster than formal guidance.

Annex 1 and Contamination Control Strategies

The implementation of Annex 1 has significantly raised expectations for contamination control. Companies must now demonstrate a comprehensive, lifecycle-wide Contamination Control Strategy (CCS) that integrates facility design, process controls, personnel practices, and environmental monitoring.

The summit will feature a dedicated workshop focused on building and implementing robust CCS frameworks, giving participants the opportunity to work through real-world scenarios and common inspection findings.

Quality in Advanced Therapies and Personalised Medicine

The rise of advanced therapies, including cell and gene therapies, is challenging traditional quality frameworks. Decentralised manufacturing, patient-specific materials, and complex logistics introduce new levels of variability and supply chain complexity.

Sessions will explore how organisations can adapt quality principles to these emerging models, balancing regulatory expectations with the flexibility and scalability required for advanced therapy manufacturing.

Digital Transformation and Data Integrity

Digitalisation is now a cornerstone of modern quality systems, but it brings its own compliance demands. System validation, data governance, and cybersecurity require close alignment between quality, IT, and operational teams.

Through case studies and expert insights, the summit will examine how organisations can avoid fragmentation and ensure governance structures keep pace with digital adoption.

Inspection Readiness as a Continuous Capability

Regulators increasingly expect organisations to demonstrate control and transparency at any time, not just during scheduled inspections. As a result, inspection readiness is becoming a continuous operational state.

Achieving this requires embedding accountability into everyday processes, supported by strong documentation practices, robust Quality Management Systems (QMS), and clear ownership across the organisation.

Who Should Attend

The summit is designed for senior professionals responsible for quality and compliance across pharmaceutical and biotechnology organisations. Attendees will gain insights from both industry and regulatory perspectives, with confirmed speakers from leading organisations including Takeda Pharmaceutical Company, Novo Nordisk, Sandoz, Pfizer, as well as representatives from Medicines and Healthcare products Regulatory Agency (MHRA) and International Society for Pharmaceutical Engineering (ISPE).

Programme Format

This two-day, in-person event combines keynote presentations, case studies, panel discussions, and interactive workshops. With over 20 expert speakers, the programme is designed with a strong emphasis on practical application, helping participants translate insights into real-world improvements within their own organisations.

View full agenda and join the summit here.