The 2026 ISPE Europe Annual Conference marked a significant milestone for the global pharmaceutical community, reinforcing ISPE’s role as a hub for innovation, collaboration, and professional development. Held in the vibrant and forward-thinking city of Copenhagen, Denmark, this year’s conference stood out not only for its record-breaking attendance, but also for the depth and diversity of...

I believe that ISPE is not just an organization. It is a global community united by a shared purpose. In March the 2026 ISPE Aseptic Conference in Washington, D.C., USA, was an example of this. The level of engagement, professionalism, and openness to learning was clear in every session, every hallway conversation, and every interaction in the Expo Hall.

A panel discussion at the 2026 ISPE Europe Annual Conference brought together leading regulators from Europe and the US to explore how regulatory leadership is evolving in an era of rapid technological and scientific change, including digital transformation efforts, GMP modernization, the maturation of quality risk management, and introduction of artificial intelligence (AI). The panel also...

How do you validate a dynamic system? In regulated life science environments, AI is now operational as part of a variety of applications, such as batch disposition assistance, pharmacovigilance signal detection, deviation filtering, and clinical trial data reviews. However, with accelerating deployments, there is an essential question which will need to be addressed: how can we apply current...

The pharmaceutical industry is experiencing a period of unprecedented growth and transformation. Shifting global dynamics, supply chain vulnerabilities and rising healthcare demands have catalyzed a surge in domestic investment, particularly in the United States. According to Frost &...

In April 2026, the ISPE United Kingdom Affiliate exhibited at the Making Pharmaceuticals conference. With a program spanning regulatory insights, good manufacturing practice (GMP) discussions, and practical case studies, the event created space for open, experience-led exchange across the industry.

As a pharmaceutical process transitions from early commercial launch into mature continued process verification (Stage 3b CPV), the primary goal is to maintain a predictable state of control. During this stage, manufacturers rely heavily on statistical process control (SPC) and run rules to detect process drift.

The 2026 ISPE Facilities of the Future Conference, held this past February in San Diego, CA, USA, was marked by a high level of energy, openness, and thoughtful engagement. Global experts, regulators, academics, students and recent graduates, and industry professionals were actively engaging with each other, from technical discussions and hallway conversations to shared meals and impromptu...

As the pharmaceutical industry continues to evolve at an unprecedented pace, the 2026 ISPE Annual Meeting & Expo arrives at a critical moment. With accelerating scientific innovation, evolving regulatory expectations, and increasing global interconnectivity, organizations are being challenged to adapt faster than ever...

In today’s pharmaceutical manufacturing landscape, ensuring product quality and patient safety while accelerating time to market has never been more critical. This recent Addendum provides further clarity, practical insights, and implementation recommendations to help organizations optimize their C&Q delivery processes.

First-ever US Food and Drug Administration (US FDA) Current Good Manufacturing Practice (cGMP) Warning Letter Citing Inappropriate Use of Artificial Intelligence (AI) in Pharmaceutical Manufacturing

ISPE marked a major milestone at the 2025 ISPE Annual Meeting & Expo, celebrating 45 years of progress while surpassing 25,000 members worldwide and reaching more than 100,000...

Rick Friedman, Deputy Director of the US Food and Drug Administration (US FDA) Office of Manufacturing Quality, opened the 2026 ISPE Aseptic Conference with a frank look at how far pharmaceutical manufacturing has come—and a candid reminder of how much is still at stake.

On the evening of Monday, 20 April, the semiannual ISPE Volunteer Recognition event was held in conjunction with the 2026 ISPE Europe Annual Conference, where we had the distinct pleasure of hosting more than 110 of our incredible global volunteer leaders at the SOHO Kødbyen (Chow Room) in Copenhagen, Denmark for a special evening of appreciation and connection.

The rapid evolution of AI is reshaping medicine regulation, shifting the technology from exploratory pilots to becoming a structural capability. A keynote presentation by Hilmar Hamann, PhD, Head of the Information Management Division at the European Medicines Agency (EMA), explored the “shifting frontiers” of the current landscape that will define how AI is developed, governed, and trusted...

Regulatory inspections by the US Food and Drug Administration (US FDA) and other global authorities require pharmaceutical manufacturers to demonstrate sustained compliance with 21 CFR Parts 210/211, ICH Q7, EU GMP Annex 1, and related regulatory frameworks. Traditional inspection readiness models are reactive, labor-intensive, and dependent on significant manual documentation review and...

At the 2026 ISPE Aseptic Conference, John Arigo, PhD, Division Director of the Division of Pharmaceutical Manufacturing Assessment 2 in the Office of Pharmaceutical Manufacturing Assessment (OPMA) at the US Food and Drug Administration (US FDA),...

Mentorship plays an essential role in sustaining and advancing the life sciences and pharmaceutical engineering industries. As new professionals enter an increasingly complex and specialized field, guidance from experienced practitioners can help transform academic knowledge into real‑world impact. ISPE has long recognized this need, fostering programs that connect students and early‑career...

Engineering does not change with press releases, conference declarations, or digital transformation slogans. It changes when the accumulated friction in delivery models becomes too expensive, too slow, and too risky to defend. Said differently, it changes when the inefficiencies that are tolerated quietly become liabilities that can no longer be justified financially, operationally, or...

In the previous installments of this series (Part One and Part Two), we discussed the development of...

AI is no longer a future concept for life sciences—it is a present-day force reshaping how medicines are developed, manufactured, regulated, and delivered to patients. Yet as AI adoption accelerates, a critical truth has become clear: technology alone is not enough. Sustainable, compliant, and scalable AI transformation depends on people, culture, governance, and organizational readiness.

This post is Part 3 of the Jack Lysfjord Grant blog series. Read Part 1 and Part 2.

The ISPE Mid-Atlantic Science and Technology Showcase (MAST) in Baltimore, Maryland, USA held on 7 May highlighted the strength, technical capability, and collaborative spirit of the life sciences industry. Hosted by the ISPE Chesapeake Bay Area Chapter at M&T Bank Stadium, the show brought together more than 950 registrants from across the pharmaceutical and biotechnology community for a...