2026 ISPE Europe Annual Conference: What to Expect and How to Prepare

Probably the best conference in the world! 

Anders Widov

When the slogan was first proposed, it was already clear that the conference had strong momentum. However, when it was shared with members of the planning committee—particularly those based in the US—there was some hesitation. Could such a claim be justified? The setting offered a compelling backdrop: Copenhagen, with a conference dinner hosted at Carlsberg. (For readers unfamiliar with Carlsberg’s slogan from 1973–2011, a quick search provides useful context.)

Momentum continues to build. More than 200 submissions made the committee’s selection process both challenging and rewarding, with many high quality proposals ultimately turned away. The exhibition area sold out months ahead of the conference, and additional companies continue to express interest. Attendance is expected to be the highest ever for the 2026 ISPE Europe Annual Conference.

Knowledge: The volume and quality of submissions point to a strong program of presentations.

Community: High delegate participation is expected to drive robust discussion and exchange.

Innovation: Multiple tracks will address innovation across the industry.

From regulatory strategy and sustainability to digital compliance and Pharma 4.0™, the 2026 ISPE Europe Annual Conference will bring together industry, suppliers, and regulators for practical discussions and networking. Here are the key themes to look out for, questions to ask, and a few ideas on how to get the most out of the event.

How It Begins

For some, the conference starts on Saturday morning, 18 April. That is when the 2026 ISPE International Emerging Leader Hackathon begins. This program challenges university students and recent graduates to address two industry relevant problems over an intensive 40 hour period. In addition to applied problem solving, the experience fosters professional connections that may continue as participants progress into future leadership roles.

Overview

The conference will spotlight what many are seeing across the sector: expectations are rising—on compliance, transparency, supply reliability, and sustainability—while technology is changing how we design, qualify, and run facilities.

• Audience: Industry professionals, suppliers, consultants, and regulators
• Format: General sessions, concurrent tracks, live interactive forums, and informal networking throughout the conference

Keynotes

The conference will open with a keynote address by Lars Fruergaard Jørgensen, former CEO of Novo Nordisk and current Chair of the Board of Directors, Healthcare Denmark. The program also includes two keynote sessions from the European Medicines Agency, a keynote from Eli Lilly and Company, and additional presentations from industry leaders and regulators.

Regulatory and Quality Track

These sessions explore the intersection of regulatory expectations with quality, continuous improvement, and innovation. Attendees can expect discussion of practical approaches to inspection readiness, management of post approval changes, and strategies for sustaining consistent, right first time regulatory submissions.

Sustainability and Substances of Concern Track

Sessions on sustainability and substances of concern will focus on practical implementation, including approaches to reducing water and energy consumption, managing chemicals and waste streams, and designing systems with full lifecycle performance in mind. Discussions will also address the evaluation of alternative substances and evolving EU regulatory expectations in this area.

Pharma 4.0™ in Action Track

Pharma 4.0 sessions will examine value creation through data driven approaches, including improving process robustness, shifting from periodic review to continuous verification, and developing systems that enable faster learning cycles. Case examples will highlight the underlying enablers of successful implementations, such as governance frameworks, master data management, and organizational change considerations.

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

The GEP and GMP track emphasizes foundational engineering principles that support product quality and operational reliability. Sessions will address practical topics such as contamination control strategies, facility and utility design considerations, approaches to improving commissioning and qualification efficiency, and methods for integrating risk management into routine operational practices.

Digital Compliance Track

Digital compliance sessions will focus on practical approaches to data integrity, including clear ownership models, audit trails that support traceability, and validation strategies designed to accommodate ongoing change. The sessions will also examine how organizations can align information technology, operational technology, and cybersecurity functions so that compliance frameworks enable—rather than constrain—innovation.

Agenda Planning (to Be Completed Throughout the Conference)

• Priority practical sessions: Which sessions offer the most relevant insights to apply in current responsibilities?
• Discussion question: Which topics or assumptions would benefit from challenge or deeper exploration with speakers or peers?
• Approach to evaluate: Where could the ideas or approaches discussed be applied within existing workstreams?
• Networking objectives: Which participants are engaged in similar areas, and where are opportunities to connect?

First-Hand Insights from the Author

According to the author: “People attend conferences for different reasons. At my first ISPE Annual Meeting & Expo many years ago, the focus was primarily on the presentations. Over time, it became clear just how much value comes from networking throughout the event. Today, there is a third pillar as well—reconnecting with lifelong friends.

One colleague I met on the dance floor later called late on a Saturday evening when her factory experienced a water issue, and together we worked through the problem. A consultant I spoke with over lunch was later connected—four months afterward—with a local validation supplier, and they continue to work together more than 10 years later. Another consultant I met over a glass of champagne went on to consult with me extensively and ultimately purchased a plant from colleagues in his home country.

We learn together. We eat together. We work together. We even sing together—some of us.”

Next Steps

Attendees may benefit from comparing agendas with colleagues to broaden coverage across sessions. Those not attending can share priority challenges—such as Annex 1 implementation, digital validation, or sustainability in utilities—with participants and ask them to identify relevant sessions, contacts, and practical examples to report back after the event. Where scheduling conflicts arise, coordination among attendees can help ensure key sessions are covered and insights shared.

How It Concludes

On Thursday morning, 23 April, a site visit to Hillerød, Denmark, is scheduled for facility tour registrants, with transportation provided by bus. Participants will have the opportunity to visit FUJIFILM Biotechnologies, one of the world’s largest biotech contract development and manufacturing organizations (based on its biologics capacity). The site is focused on reducing water and energy consumption and lowering emissions. Capacity for the visit is limited to 30 participants, and advance registration is required due to limited availability.

Learn more and register for the 2026 ISPE Europe Annual Conference today.