2026 ISPE Europe Annual Conference: The Pulse of Transformation

Regulatory Challenges

Starting with the evolving regulatory landscape and extending to the integration of artificial intelligence (AI) in decision-making processes, the transformation touches every facet of the industry. It encompasses the rapid expansion of new therapeutic modalities—e.g., advanced therapy medicinal products (ATMPs), RNA-based treatments, radiopharmaceuticals, and antibody-drug conjugates—alongside the digitalization of processes or the agile design and construction of modern manufacturing facilities.

Sustainability has become a critical priority, driving efforts to reduce net greenhouse gas emissions and eliminate substances of concern such as per- and polyfluoroalkyl substances (PFAS). At the same time, the industry must address pressing challenges like drug shortages. Collectively, these developments signal a dramatic acceleration for a sector that has traditionally advanced at a measured, step-by-step pace. In recent years, the industry has recognized the need to improve efficiency and speed to ensure the timely delivery of high-quality, safe medicines to patients.

At the same time, the pharmaceutical community remains committed to collaboration. This spirit of openness, combined with the industry’s ongoing transformation, has resulted in a record number of proposals for the 2026 ISPE Europe Annual Conference—each from those eager to share ideas and showcase progress to date. For the organizing committee, this is both a privilege and a responsibility. It is also a guarantee that the program will deliver valuable insights that reflect the current realities of the pharmaceutical industry.

It encompasses the rapid expansion of new therapeutic modalities—e.g., advanced therapy medicinal products (ATMPs), RNA-based treatments, radiopharmaceuticals, and antibody-drug conjugates—alongside the digitalization of processes or the agile design and construction of modern manufacturing facilities.

Innovation

Innovation is also part of ISPE’s DNA. To foster dialogue, the program will feature live interactive forums covering multiple topics. This new format introduces mini panels designed to encourage active participation, moving beyond the traditional passive listening approach. Attendees will take an active role—proposing ideas, defending viewpoints, learning from peers, and sharing experiences—creating a dynamic environment for collaboration and knowledge exchange.

Keynotes From Top Industry Leaders

Industry leaders representing major manufacturers and representatives from the European Medicines Agency and US Food and Drug Administration will deliver the keynote sessions. These leaders include Lars Fruergaard Jorgensen, Chair, Healthcare Denmark, and former President and CEO at Novo Nordisk; Lars Petersen, President and CEO, Fujifilm Biotechnologies; and Susanne Hundsbæk Pedersen, Global Head, Pharma Technical Operations EVP, Roche.

These keynotes are designed to reflect the current state of the pharmaceutical industry, provide a forward-looking vision, and share strong examples from development programs. In addition, an external keynote will soon be announced, offering insights into achievements in other industries as a source of inspiration. To reinforce the ultimate purpose of our work, a patient will also take the stage, providing a powerful perspective from the client side and reminding us of the importance of timely, safe, and effective medicines.

Five Conference Tracks

The 2026 ISPE Europe Annual Conference is organized into five core content areas, each encompassing multiple topics. A strong emphasis has been placed on presenting case studies that demonstrate real work currently in progress or recently completed within the pharmaceutical industry. These sessions also highlight collaborative efforts aimed at identifying key challenges and delivering practical, innovative solutions.

Digital Regulatory Compliance

This track explores how emerging digital tools—such as cloud technologies, AI, and next-generation automation—must embed regulatory compliance by design within processes and systems. Key topics include GxPs in the context of AI, the shift from document-based to record/data-based documentation, and good data management (e.g., data integrity and enabling informed decision-making processes).

Pharma 4.0™ Use Cases

This track offers a strategic and practical overview of how digital technologies are transforming pharmaceutical manufacturing. This track features numerous case studies, including applying AI to accelerate chemistry, manufacturing, and controls documentation; advanced digitalization in personalized medicine; autonomous robotic cell therapy; virtual engineering; and leveraging production data for smart maintenance. The need of underlying business cases will be addressed, as well as expected outcomes, benefits, and risk management.

Good Engineering Practices (GEP) and Good Manufacturing Practices (GMP)-Compliant Project Delivery

This track is focused on GEP and efficient investment strategies for GMP-compliant project delivery in pharmaceutical and biopharmaceutical sectors. Highlights include four European Facility of the Year Awards (FOYA) winners, lessons learned in newly completed capital expenditures engineering projects such as radiopharmaceutical facilities, and practical insights on implementing closed system designs in line with Annex 1 expectations.

Sustainability and Substances of Concern

This track addresses two critical areas. Besides classical environmental, health, and safety topics like water, air, and energy, there is also focus on sustainability at the product level, specifically using the right chemicals for active pharmaceutical ingredient (API) manufacturing and excipients for finished products. On substances of concern, discussions will focus on alternatives to PFAS (per- and polyfluoroalkyl substances) and strategies to mitigate the risk of nitrosamine impurities in human medicines. On sustainability, the track will explore innovative processes to reduce utility consumption and approaches to designing efficient, environmentally responsible systems.

Regulatory and Quality

There are many new regulations in the pipeline. There is the “Pharmaceutical Package” (192 and 193), a set of proposals by the European Commission aimed at revising and modernizing European Union (EU) pharmaceutical legislation that will impact current regulations for drug approvals and broad range updates to GxP (e.g., Annex 11, Annex 15, and Annex 22), regulation for avoidance of drug shortages, and more. Relevant for operations include:

• Revised regulatory data protection
• Clinical assessments for oncology products and ATMPs
• Critical Medicines Act with mandatory supply chain risk assessments and requirements for EU-based manufacturing for critical APIs
• Emergency intervention powers for EU authorities
• More stringent environmental risk assessments, also including legacy products
• Tighter control for API emissions, wastewater discharge, and carbon footprint reporting

Much more awaits 2026 ISPE Europe Annual Conference attendees, including Spotlight Sessions in the exhibitor hall—an opportunity for service providers to deliver concise presentations showcasing innovative products that address current manufacturing challenges. This space will also serve as the stage for the introduction of new ISPE Guides, presented directly by their authors, offering attendees firsthand insights into the latest industry standards and best practices.

ISPE anticipates a record number of participants: Don’t wait, secure a spot today and be part of this transformative event. This conference is everyone’s conference. ISPE and the organizing committee are simply the enablers, creating the platform for dialogue, learning, and collaboration. Join the community, share expertise, and leave energized with fresh ideas and connections.

Learn More about the 2026 ISPE Europe Annual Conference