ISPE NL

Every GxP conversation about AI eventually hits the same wall. Your validation framework assumes determinism. Same input, same output, documented, reproducible, signed. That assumption is doing a lot of quiet load-bearing work in GAMP 5. Generative models break it. Agentic systems break it enthusiastically. The 9th ISPE Pharma 4.0 survey suggests the industry is deploying AI anyway: AI came out as the most adopted enabling technology, while validation and governance came out as the top blockers. Both things are true at once, which is usually a sign that people are solving it locally and nobody has written it down. Teresa Minero walks through what the data actually says on 17 September at 11:55. Genuinely curious what the QA side of my network thinks here. Are you validating these systems, or are you keeping them out of GxP scope entirely? Registration link in the first comment. ISPE ISPE NL ISPE D/A/CH - Germany, Austria, Switzerland ISPE Belgium Affiliate vzw ISPE Italy Affiliate ISPE European Affiliate Emerging Leaders Teresa Minero Danny Groothuis Thilo M. Buck Kees Mensch Carmen Berends Margrit Fares Mikhaeil Christian Wölbeling Paige Kane, PhD, CPIP Michelle Vuolo Yvonne Duckworth, PE Dirk Wollaert

Lunch & Learn | The 9th ISPE Pharma 4.0™ Survey: Where Are We Now? On Thursday 17 September, 12:00–13:00 CEST, the ISPE NL Pharma 4.0™ Community of Practice hosts Teresa Minero for a one-hour online session on the ninth edition of the ISPE Pharma 4.0™ Survey. The survey has tracked digital maturity across the life sciences industry since 2017, presented each year at ISPE events worldwide. The ninth edition adds four new questions, all on artificial intelligence in GxP operations: • Which AI applications are being piloted or rolled out in GxP • How organisations are approaching AI adoption today • Which skill gaps are blocking implementation • Which challenges dominate cybersecurity in Pharma 4.0 initiatives Teresa Minero is Founder of LifeBee, now part of ProductLife Group, and chairs ISPE’s Digital Transformation Advisory Committee for the International Board of Directors. She has been an active ISPE member since 1993. Free to attend. https://lnkd.in/e7JXTjKm ISPE ISPE NL ISPE Nordic Affiliate ISPE Italy Affiliate ISPE Belgium ISPE Belgium Affiliate vzw ISPE D/A/CH - Germany, Austria, Switzerland Carmen Berends Margrit Fares Mikhaeil Danny Groothuis Thilo M. Buck Teresa Minero Marc Vorderman Rene Fischer

We expected twelve topics. We got one argument. On Wednesday 21 May at 12:00 CET, Thilo Buck and I reflect at fifteen months of ISPE Netherlands Pharma 4.0 Lunch Talks — and try to say honestly what we actually heard. Across eleven sessions and thirteen speakers — from ISPE leadership to insights on operating sites at — one shift kept surfacing in different vocabularies: 📌 From documents as the unit of truth, to data as the unit of truth. This closing webinar isn't a recap. It's a working session. ✦ A working definition of holistic digital manufacturing maturity — where do you actually sit? ✦ Six provocations engineered to surface disagreement, not consensus ✦ Five anonymous polls — including the one that shapes our autumn programme ✦ A direct ask: what do you want us to go deeper on next? If you've followed even one talk in the series, this is the one to attend. We owe you the synthesis. 🗓️ Thursday 21 May 2026 · 12:00–13:00 CET · MS Teams 🔗 Register: https://lnkd.in/e7zQ9e_U Huge thanks to Thomas Zimmer Emmie Heeren Christian Wölbeling Vinzenz Zauner Heike Roeder Wolfgang W. Matthias Kress James Sunna Michelangelo Canzoneri Dr. Achim Schuster Marcel B. Danilo Neri Dr. Markus Zeitz for fifteen months of substance. EXCLUSIVE SPONSOR Adryan is Proud to Be the Exclusive Sponsor of the ISPE NL Pharma 4.0 Lunch Talks Series At Adryan, we believe in driving innovation and collaboration within the pharmaceutical industry. That’s why we are proud to be the sole sponsor of the ISPE Netherlands Pharma 4.0 Lunch Talks Series — a platform dedicated to exploring the future of pharma through digital transformation, smart manufacturing, and regulatory innovation. By supporting this initiative, Adryan reaffirms its commitment to advancing Pharma 4.0 and fostering meaningful dialogue among industry leaders, experts, and innovators. Let’s shape the future of pharma, together. www.adryan.com → ISPE ISPE NL ISPE D/A/CH - Germany, Austria, Switzerland ISPE Chesapeake Bay Area Chapter ISPE India Pharma 4.0 COP ISPE United Kingdom Pharma 4.0 COP Carmen Berends Thilo M. Buck Michiel van Hoeven Danny Groothuis Adryan

Exciting times ahead with the ISPE NL Pharma 4.0 Community of Practice 🚀 Four upcoming sessions worth blocking in your calendar: 🔹 May 21 — Lunch Talk: "Pharma 4.0 in Action – an Overview" with Kees & Thilo. A reflective, discussion-driven session on what we've learned over the past 1.5 years. How mature is Pharma 4.0 really? Where does AI actually fit — hype, helper, or game changer? Free registration at: https://lnkd.in/ePKvtMJi 🔹 June 3 — "Why Pharma? From Smooth Production to Public Health" in Leiden. Designed for students and Emerging Leaders curious about how the industry really works. Expert speakers, panel discussion, pub quiz, drinks. Registration at: https://lnkd.in/eBucpJcX 🔹 June 11 — Pharma 4.0 Round Table (live in Leiden & online). Limited to 15 participants for real knowledge exchange. ISPE members only. Registration at https://lnkd.in/e7BpnRT9 🔹 June 18 — Lunch Talk with Dirk Wollaert: a 30-minute blueprint to map, govern, and scale your data management using ISA-95 and an Open Architecture approach. Free registration here: https://lnkd.in/e6JmnSfD Huge thanks to Adryan for being the exclusive sponsor of the Lunch Talks series and supporting open dialogue in our industry. Feel free to check out www.adryan.com Which one will you join? ISPE ISPE NL ISPE Chesapeake Bay Area Chapter ISPE D/A/CH - Germany, Austria, Switzerland ISPE United Kingdom Pharma 4.0 COP Thilo M. Buck Carmen Berends Danny Groothuis Michiel van Hoeven Adryan Dirk Wollaert Pieter Carrière, MSc Christian Wölbeling Jörn Volckmann Dr. Markus Zeitz Danilo Neri Dr. Achim Schuster Matthias Kress Marcel B. Emmie Heeren

Next CoP P4.0 lunchtalk - May 21st - 12:00 - 13:00 - Register now: https://lnkd.in/ePKvtMJi Over the past one and a half year, the ISPE NL Pharma 4.0 Lunch Talk series explored key themes from the ISPE Pharma 4.0™ Best Practice Guide, ranging from strategy and architecture to compliance and organizational maturity. In this session, Kees and Thilo will zoom out and reflect on the most important insights and lessons learned from these discussions. Rather than another slide-heavy presentation, this lunch talk will be highly interactive and discussion-driven. Together with the audience, we will tackle the burning questions that keep coming back: How mature is Pharma 4.0 really? How do we balance innovation with GMP compliance? And what is the realistic role of AI today — hype, helper, or game changer? Expect a concise overview, honest reflections from the field, and an open conversation aimed at turning Pharma 4.0 from concept into practical reality. Register now: https://lnkd.in/ePKvtMJi May 21st - 12:00 - 13:00 Proudly sponsored by Adryan Exclusive sponsor of the ISPE NL Pharma 4.0 Lunch Talk Series At Adryan, we support the transition to digital, risk‑based validation and the practical adoption of Pharma 4.0 principles. ISPE ISPE NL ISPE D/A/CH - Germany, Austria, Switzerland ISPE Chesapeake Bay Area Chapter Thilo M. Buck Adryan Thomas Zimmer Emmie Heeren Christian Wölbeling Vinzenz Zauner Heike Roeder Wolfgang W. James Sunna Matthias Kress Sana A. Christoph Herwig Jörn Volckmann Michelangelo Canzoneri Dr. Achim Schuster Marcel B. Danilo Neri Dr. Markus Zeitz Dirk Wollaert Michiel van Hoeven Danny Groothuis Carmen Berends

🔍 From paper-based validation to eValidation in practice — and what’s next for Digital Quality During our recent ISPE NL Pharma 4.0 CoP lunch talk (19 March), Marcel Boere (Delpharm) shared a refreshingly honest journey: not just the ambition to move away from paper-based validation, but what it actually takes to make eValidation work in practice. Key takeaways: Secure top management buy‑in early for initiatives of this scale Avoid “paper to glass” — rethink validation from first principles Connect patients, products, processes, and systems in one coherent framework Use a database‑driven, risk‑based approach to improve efficiency, traceability, and data integrity Marcel also openly reflected on the challenges: defending review‑by‑exception during inspections, real‑time release still being work in progress, and the limitations of proprietary systems. His project reflections were clear: set the ambition level right, keep space for customization, and stay close to operations — innovation often requires crossing established boundaries. 👉 Looking ahead On April 16, 2026, ISPE NL Pharma 4.0 hosts the next Lunch Talk on Digitalized Quality & Pharma 4.0, spotlighting the upcoming ISPE Digital Quality Best Practice Guide. 🎤 Speakers Danilo Neri (PQE Group) Dr. Markus Zeitz (Takeda), Chair of the ISPE Digital Quality GPG Working Group They will explore: ✅ Why the guide was initiated ✅ How Digital Quality enables Pharma 4.0 ✅ Moving from quality “islands” to connected ecosystems ✅ Data governance, AI readiness, and real‑world GxP use cases 📅 Register here: 👉 https://lnkd.in/enjtK7H2 Looking forward to continuing the conversation on turning compliance into scalable, continuous value. Proudly sponsored by Adryan Exclusive sponsor of the ISPE NL Pharma 4.0 Lunch Talk Series At Adryan, we support the transition to digital, risk‑based validation and the practical adoption of Pharma 4.0 principles. ISPE ISPE D/A/CH - Germany, Austria, Switzerland ISPE Chesapeake Bay Area Chapter ISPE UK Affiliate ISPE UK Affiliate C&Q COP ISPE Ireland Affiliate ISPE NL Thomas Zimmer Christian Wölbeling Emmie Heeren Matthias Kress Vinzenz Zauner Michelangelo Canzoneri Marcel B. Dr. Achim Schuster Dr. Markus Zeitz Danilo Neri Dr. Achim Schuster Dirk Wollaert Heike Roeder Thilo M. Buck Carmen Berends Michiel van Hoeven Danny Groothuis