.

Annex 1 has redefined expectations around contamination control and aseptic processing. Simultaneously, the rise of Advanced Therapy Medicinal Products (ATMPs) has challenged traditional manufacturing workflows. At the same time, organizations are under pressure to digitize quality processes, adopt data-driven decision-making, and explore artificial intelligence within GxP environments. They also maintain inspection readiness and ensure data integrity.

In this context, quality became a strategic discipline that determines operational resilience and patient safety. Against this backdrop, Fleming is convening the Pharma and Biotech Quality Summit on 12–13 May 2026 at the Leonardo Hotel Munich Arabellapark, Germany.

The 2-day summit brings together senior quality professionals from world's leading pharmaceutical and biotech organizations, for what promises to be one of the most substantive gatherings on quality strategy in Europe this year.

Who Will Be in the Room

The speaker lineup includes senior industry leaders from organizations such as Takeda, Pfizer, Lonza, Novo Nordisk, Fresenius Kabi, Kyowa Kirin, and ESTEVE, alongside regulatory perspective from the MHRA and scientific leadership from ISPE.

This combination of industry quality leaders, regulatory authorities, and scientific bodies gives the summit a rare breadth and enable cross-functional dialogue that rarely happens within a single organization.

From Compliance to Strategic Control

The summit's programme is structured around a central theme: the shift from reactive compliance management to integrated, risk-based quality systems. Sessions will cover Quality by Design (QbD) principles extended into commercial manufacturing, ATMP manufacturing, building holistic Contamination Control Strategies (CCS) aligned with Annex 1, integrating QMS, MES, and LIMS platforms with data integrity by design, and deploying AI within GxP-regulated environments in a defensible and validated way, and the integration of digital quality platforms.

2 dedicated workshop sessions allow attendees to work through implementation challenges in a peer-learning environment alongside 15+ presentations and over 6 hours of networking.

For quality leaders navigating board-level pressure, the summit offers a strategic perspective from peers who have faced the same decisions, and practical frameworks ready to take back into operations.