The International Society for Pharmaceutical Engineering - ISPE

05/02/2026

Artificial intelligence is rapidly becoming part of day-to-day pharmaceutical manufacturing—but successful adoption depends on more than technology. It requires a workforce that is trained, competent, and prepared to integrate AI thoughtfully and responsibly, in compliance with GMP expectations.

In the latest episode of the ISPE Podcast: Shaping the Future of Pharma, host Bob Chew sits down with Susan Szathmary and Richard Jaenisch of the Open Biopharma Research and Training Institute for a wide-ranging conversation on how applied AI is already influencing workforce development and manufacturing operations.

Drawing on their experience leading a nonprofit, industry-focused training institute, the guests discuss how AI can be used. Listen to the full episode: https://bit.ly/3QHOJYd

05/01/2026

Of more than 150 applicants in the program's first year, nine emerging pharmaceutical professionals were selected to receive the inaugural Jack Lysfjord Grant, which supported their attendance at the 2026 ISPE Aseptic Conference. They arrived in Washington, D.C., USA as students and early-career professionals. They left as something more—connected, challenged, and with a clearer sense of where they fit in this industry.

Read more in this iSpeak blog by Mike Martin: https://bit.ly/4t9arSm

04/30/2026

Are you ready to share innovative strategies, breakthrough concepts, or proven best practices with your industry peers? The 2026 ISPE Pharma 4.0™ and Biopharma Conference, taking place 10–11 December in Berlin, Germany, is your opportunity to make an impact and showcase your work to the global life sciences community.

Submit your proposal now: https://hubs.la/Q04f4cC50

Present your expertise in one of these key content areas:
• Digital Foundation and Enablers for Pharma 4.0
• Regulatory Updates on Pharma 4.0 and New Biologics
• Biotech Applications and Benefits of Pharma 4.0
• Scalable Pharma 4.0: From Innovation to Real-World Smart Manufacturing
• Innovation and Technology: Driving a Pharma 4.0 Future, Forward-Looking Advances and Emerging Concepts

04/29/2026

A new addendum to the ISPE Baseline® Guide: Commissioning and Qualification (Second Edition) has just been released, and it's available to you at no cost.

The QRM Addendum – C&Q Delivery Process provides an overview of the commissioning and qualification (C&Q) delivery process, along with implementation recommendations for applying quality risk management (QRM) to the qualification of facilities, systems, utilities, and equipment.

Download your complimentary addendum and learn more about the Guide: https://hubs.la/Q04dWH0Y0

04/28/2026

AI is no longer a distant or experimental concept within pharmaceutical and biotechnology organizations. Across laboratories, manufacturing operations, and quality systems, AI-enabled tools are increasingly being piloted to accelerate insights, strengthen decision-making, and improve operational efficiency. Yet despite growing enthusiasm, many organizations encounter a consistent and familiar challenge: moving beyond promising pilots and into compliant, production-ready systems that can withstand regulatory scrutiny and scale sustainably.

Read more in this iSpeak blog by Cameron Gill: https://hubs.ly/Q04dPrjj0

04/28/2026

Explore a new way to learn with ISPE. Introducing Microlearning: a new on-demand training opportunity designed to deliver focused, practical content in a flexible, self-paced format.

Our first offering in this format is GAMP® Basic Principles. Specifically designed for professionals balancing career development with demanding schedules, each module focuses on a key aspect of GAMP 5 and its practical application—covering everything from system lifecycle management and data integrity to computer software assurance, AI, and machine learning.

Learn more: https://hubs.la/Q04dMfPR0

04/27/2026

Digital transformation and emerging technologies such as AI and machine learning (ML) are driving a technological revolution across the entire product lifecycle. A critical area of focus is the GMP-regulated segment of the supply chain. An industry-regulator panel at the 2025 ISPE Pharma 4.0™ Conference last December exchanged views on how to foster AI/ML innovation without compromising safety and efficacy.

Read more in this iSpeak blog:

The pharmaceutical industry is undergoing a technological revolution, driven by digital transformation and emerging technologies such as AI/machine learning (ML). These innovations are being applied across the entire product lifecycle from research and development and clinical development to manufac...

04/23/2026

Attendees of the 2026 ISPE Europe Annual Conference had the opportunity to go behind the scenes at the FUJIFILM Biotechnologies site in Hillerød, Denmark, to see how advanced biologics are brought to scale. Moving through the impressive 120,000-liter facility, the group observed how large-scale commercial capacity and rigorous sustainability standards work in tandem.

Thank you to the team at FUJIFILM Biotechnologies for hosting our ISPE community and sharing your commitment to manufacturing excellence.

04/23/2026

ISPE extends its sincere gratitude to the International Program Committee, the ISPE International Board of Directors, and our dedicated attendees, exhibitors, and sponsors who made the 2026 ISPE Europe Annual Conference possible.

Together, we achieved a milestone by making this the largest Europe Annual Conference in our history. Your commitment continues to Shape the Future of Pharma. Check out the moments and experiences that defined this event: https://hubs.la/Q04d31st0

International Program Committee
- David Estape (Chair)
- Liz Dooley (International Board Liaison)
- Anders Widov (Affiliate Liaison)
- Manuela Ghebreyesus (Women in Pharma® Liaison)
- Angelo Bernardis
- Estelle Darnon
- Yvonne Duckworth
- Oliver Herrmann
- Cristina Mazo
- Darragh McDonagh
- Soren Pedersen
- Alfred Penfold
- Alice Redmond, PhD
- Josef Trapl
- Heather Watson
- Niels De Blende (Emerging Leader)
- Georgina Hunter (Emerging Leader)
- Kenza Kanzari (Emerging Leader)
- Laura Kuger (Emerging Leader)
- Rebecca Roscher (Emerging Leader)
- Marek Broch Sznitko (Emerging Leader)

Sponsors
- Arcadis
- CAI
- eConsulting
- Emerson
- Fluor
- GTS Nordic
- io-consultants GmbH & Co. KG
- Jacobs
- Mithryl Czechia s.r.o.
- Novo Nordisk
- Ortner Reinraumtechnik GmbH
- Roche
- SANI Membranes A/S
- Sartorius
- Schneider Electric
- Sisk
- SteelcoBelimed
- Veeva Systems

Media Partners
- IPQ

Mark your calendars now for the 2027 ISPE Europe Annual Conference. The excitement continues, 10-12 May 2027 in Prague, Czech Republic. You won't want to miss what we have planned next. Learn more at:https://hubs.la/Q04d33SZ0

04/22/2026

As we close out the 2026 ISPE Europe Annual Conference, our final sessions focused on the intersection of advanced technology and regulatory agility.

Highlights included:
• Tala Fakhouri, PhD of Parexel International, led a discussion on applying AI responsibly. The focus was on proportionate validation, ensuring that as we integrate AI into regulated environments, our validation frameworks remain robust yet adaptable.
• Evdokia Korakianiti of the EMA reminded us that innovation only matters if it reaches our patients. When we engage early on and openly, we can bring better medicine and treatments to patients faster.
• Our final panel engaged in a thoughtful dialogue on the most urgent regulatory priorities. We explored current bottlenecks and the proactive steps required to prepare global regulatory systems for the next generation of pharmaceutical technologies.

What was your most impactful takeaway from this year’s conference? Share your thoughts below.

04/22/2026

As the 2026 ISPE Europe Annual Conference draws to a close, this morning provided valuable takeaways for attendees.

• Laura Kuger of Takeda and Teresa Minero of LifeBee shared the latest Pharma 4.0™ Survey results, offering a pulse-check on the industry's digital evolution.
• The ISPE Women in Pharma® panel explored how identical messages can be interpreted differently across cultures and generations, providing a toolkit for clearer, more intentional communication.
• Concurrent sessions delivered high-level technical expertise, providing attendees with actionable takeaways and solutions ready for immediate implementation.
• The Exhibition Area remained a hub of activity as attendees connected with exhibitors, engaged with authors at the Spotlight Sessions in the PUBlounge, and explored the cutting-edge technologies

View the highlights and memorable moments from the conference here: https://hubs.la/Q04d1LgS0

04/21/2026

The Tuesday Networking Dinner at the 2026 ISPE Europe Annual Conference delivered an evening of pure excitement and connection. Attendees enjoyed a memorable night of fun, dancing, and great company. Thank you to all who made it so special.