The 2025 ISPE Europe Annual Conference provides a unique opportunity to delve into these essential topics and learn how the pharmaceutical industry is adapting to and thriving in this new era of innovation. Featuring a lineup of esteemed speakers, groundbreaking presentations, and in-depth discussions, the conference will focus on equipping professionals with the tools and insights necessary to navigate the complexities of modern computerized systems validation.
Reimagining Computerized System Validation in the Digital Era
As the pharmaceutical industry adopts cutting-edge technologies, there’s a growing need to shift validation from a burdensome compliance exercise to an enabler of innovation. At the 2025 ISPE Europe Annual Conference, experts will discuss how validation frameworks can evolve to manage risks effectively without stifling creativity. By focusing on critical thinking, risk-based approaches, and streamlined processes, participants will learn how to implement validation practices that enhance efficiency and maintain compliance.
The conference will feature tracks dedicated to new concepts, such as validation of artificial intelligence (AI) systems, and critical thinking applications in testing, ensuring that the validation of systems and processes aligns with today’s fast-paced technological advancements.
Workshop: Digital Transformation and GAMP®: Implementing an AI Solution in a Pharma™ 4.0 Context
Integrating innovative AI solutions serves as a cornerstone in the transition toward data-driven organizations and digital transformation. At the same time, ensuring patient safety, maintaining, and achieving regulatory compliance remain priorities within GxP-regulated areas. Examples of Pharma 4.0™ principles and GAMP® concepts help in achieving these goals, where specific maturity assessments and risk management techniques have been established for application in an AI context.
This interactive workshop led by industry subject matter experts including Paige Kane, PhD, serving on the ISPE Pharma 4.0 Advisory Board and Steering Committee, Brandi Stockton with The Triality Group, Martin Heitmann with d-fine and Frank Henrichmann with QFINITY delves into practical aspects of implementing AI in a GxP-regulated environment, guided by the principles and guidance established in ISPE Pharma 4.0 and GAMP®. Participants will explore maturity assessment techniques to evaluate organizational readiness for digital transformation, focusing on critical factors such as infrastructure, culture, and existing processes. They will also have the chance to explore a comprehensive risk assessment methodology tailored to AI solutions, focusing on methods for identifying and mitigating risks to patient safety, data integrity, and product quality.
Through real-world examples and hands-on exercises, attendees will gain actionable insights into aligning AI implementation with digitization objectives while fulfilling quality expectations and adhering to regulatory requirements.
Highlights of the GAMP Track
The GAMP track promises to be a standout feature of the conference, featuring thought leaders and subject matter experts sharing their knowledge and insights. The track will be led by Frank Henrichmann with QFINITY), Montse Alonso with Kyowa Kirin), Reano Panza with Galapagos) and Niels de Blende with BLENDED Consulting. Here are some key presentations you can look forward to:
1. “GAMP 5 Second Edition – Successes, Opportunities, and Challenges”
Presented by Sion Wyn with Conformity Limited, this session explores the impact of the updated ISPE GAMP 5 Guide (Second Edition) framework. Attendees will gain insights into how the second edition has supported high-quality computerized systems, the opportunities it unlocks, and the challenges that remain.
2. “Using Critical Thinking for Effective Risk Management”
Brendan Walshe with Integrity will dive into how critical thinking, as outlined in the ISPE GAMP 5 Guide (Second Edition), enhances risk management strategies. This session provides practical guidance for applying these principles across various computerized systems, from enterprise resource planning (ERP) to GAMP Category 3 systems.
3. “Implementing Digitalized Project Execution for Automation”
In her session, Hilary Mills-Baker will explore the integration of digitalized project execution tools, highlighting innovations in automation and AI-enabled processes. Learn about best practices for supplier engagement, role clarity, and validation workshops to optimize outcomes.
4. “Qualification and Validation of Modular Plants”
Presented by Thomas Makait with QPRI and Markus Fink with Siemens AG, this session introduces the concept of Module Type Package (MTP) for building flexible and compliant modular plants. Attendees will discover a holistic, data-driven approach to qualification and validation.
5. “Ensuring Data Integrity for Legacy Laboratory Systems”
Carsten Jasper with Charles River Laboratories Inc. will present a practical use case showcasing how to transform legacy laboratory systems into modern, compliant digital systems.
6. “Applying GAMP 5 Second Edition Key Concepts to Enable a Successful Health Cloud Platform Implementation”
Paul Irving with Northern Life Sciences and Chris Kenny with JDI Digital Transform will present a case study highlighting how the ISPE GAMP 5 Guide (Second Edition) was applied to support a leading life sciences organization in implementing and validating a modular cloud-based platform tailored for the health and life sciences sector that enables seamless connectivity between healthcare providers, patient services, and pharmacies.
AI and Digital Transformation in Focus
The conference will also address the transformative role of AI and ML in pharmaceutical development. Presentations will explore critical areas such as governance, compliance, and validation of AI-driven systems.
1. “The Human Factors of AI/Machine Learning (ML)”
Eric Staib with Syneos Health will discuss the importance of ethical considerations, transparency, and human oversight in AI system development, offering strategies for responsible deployment.
2. “Governance and Compliance of AI/ML Foundation Models”
Join Costanza Stocchi and Irene Barlachi with MAASI Enterprises and Eugenio Benedetti and Francesco Sforazzini with Siena Imaging as they delve into the challenges and opportunities of integrating AI/ML into medical imaging. This session will focus on compliance with medical device regulations and ensuring the robustness and accuracy of AI models.
3. “Digital Quality and Validation for Personalized Medicine”
Martin Heitmann with d-fine and Mohammed Rahman with Otsuka Pharmaceutical Development and Commercialization, Inc. will explore how AI, sequencing technologies, and digital biomarkers are driving personalized medicine. Learn how rigorous validation frameworks ensure regulatory compliance while optimizing patient-specific treatment plans.
Practical Strategies for Ensuring Compliance
Presentations will provide practical guidance for achieving compliance, including:
1. “Ensuring Compliance of Digital Systems at Clinical Sites: Practical Steps and Verification Strategies”
Anna Dachs with Ambit will present the essential aspects of establishing and verifying compliance for digital systems at clinical sites, focusing on practical strategies and common pitfalls.
2. “Are the Current EU GCP CSV/DI Requirements a Blueprint for Other GxPs?”
Oliver Herrmann with QFINITY will present the current regulatory expectations for good clinical practice (GCP) systems and risk an outlook for the upcoming regulatory guidance in other GxP areas.
These sessions will equip attendees with actionable strategies to meet regulatory requirements while navigating the complexities of digital transformation.
Whether you’re an executive, a validation specialist, or a quality professional, the conference will provide you with the tools and knowledge to excel in your role and contribute to the industry’s success.
Together, let’s build a future where validation is not a barrier but a catalyst for innovation and progress.
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