Agenda
Our education program offers cutting-edge technical sessions, shedding light on the latest advancements in the pharma industry.
All session times are listed in Central European Time (CET). Find your personal viewing time on the World Clock.
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Mon, 20 Apr
Tue, 21 Apr
Wed, 22 Apr
0730 – 1745
Registration
Registration will also be open on Sunday, 19 April from 1300-1800.
0830 – 0850
General Session
0850 – 0920
Global companies operate in more volatile, unpredictable, and complex times than ever before. How should companies interpret this new environment? Transient or the new normal, and what are the implications for a regulated industry like the pharmaceutical industry?
0920 – 0950
General Session
Susanne Hundsbaek-Pedersen, Roche
The pharmaceutical industry is currently facing significant challenges and opportunities that require constant re-evaluation of practices, options, and risk mitigation strategies.
The pharmaceutical industry is currently facing significant challenges and opportunities that require constant re-evaluation of practices, options, and risk mitigation strategies.
The intense environment and increasing complexity demand an adaptive approach to architecting the journey from molecule to product to patient solutions. Breaking with traditional thinking to adapt to new circumstances requires participation from every seat—internally and externally—always collaboratively. Since there is no one-size-fits-all solution, Roche will share how every function across our Technical Operations is responding to this environment under the headline: "Responding from Every Seat."
0945 – 1900
0950 – 0958
1000 – 1045
1045 – 1115
1115 – 1155
General Session
1155 – 1200
1200 – 1330
1330 – 1500
Join us for a dynamic, practice-focused program that brings Quality Risk Management to life through the lens of ICH Q9(R1). This interactive series blends expert insights, Quality Risk Management in the Light of New European Pharma Regulations, practical implementation guidance, and hands-on exercises to help participants strengthen their organization’s QRM maturity. You’ll explore key concepts such as formality, subjectivity, risk-based decision making, and knowledge management, and see how they connect to product availability and operational performance. Through real-world gap assessment approaches, regulatory and industry perspectives, and collaborative workshops, you’ll learn how to apply QRM principles effectively within your own environment. The program culminates in immersive breakout case studies of increasing complexity that allow you to apply the full QRM lifecycle initiation, assessment, control, communication, and review using different tools and decision-making approaches. Expert panels throughout the sessions provide the opportunity to deepen understanding and refine practical application. This is an ideal opportunity for professionals across QA, QC, manufacturing, supply chain, and compliance to advance their QRM capabilities with actionable, experience-based learning.
1330 – 1500
1330 – 1500
Designing, delivering, and starting up new pharmaceutical facilities—whether greenfield or brownfield—requires seamless integration of GMP compliance principles from the earliest project stages. This panel will explore strategies for embedding GMP throughout the project lifecycle, drawing on lessons learned from recent real‑world implementations and exploring alternatives to improve in efficiency and reliability.
Key themes include:
- Designing and building new manufacturing capacity in alignment with evolving GMP standards.
- Aligning regulatory and business needs between project owners, engineering teams and regulators.
- Engaging proactively with national regulatory authorities to seek guidance or approvals.
- Integrating novel technologies while maintaining compliance with established GMP frameworks.
- Embedding GMP requirements from conceptual design through commercial manufacturing readiness.
- Implementing efficient, compliant commissioning and qualification strategies that support inspection readiness.
- The role of cross‑functional collaboration in shaping compliant, future‑ready solutions.
The panelists will share insights from recent greenfield and brownfield projects, illustrating how early compliance ownership, structured coordination, and transparent decision‑making drive successful outcomes and long‑term operational excellence. The session aims to spark an open, interactive dialogue with the audience.
1330 – 1500
Pharma Open Data Space: Turning Vision into Reality - Roadmap for Resilience, Data Integrity and Business Impact
Data exchange is no longer just a technical goal; it is a survival strategy for a resilient supply chain as well as eliminating manual and error prone process steps to ensure patient safety. In this interactive forum, we move beyond the "if" and into the "how" in a regulated pharmaceutical environment. We compare Pharma's progress to breakthrough successes in industries like steel manufacturing and Construction sectors (from building facades to digital twins) to see how open data drives radical resilience. This session explores the Pharma Open Data Space (PODS) as the essential enabler for the next generation of R&D and manufacturing. We bridge the gap between vision and reality by examining what is happening outside Pharma - learning from the interoperability of the other industries - and showcasing how leaders are already implementing these frameworks. Learn how to maintain 100% data ownership while enabling seamless, secure collaboration with CDMOs and suppliers, without drowning in Excel, Word and PDF files. We will dive deep into the Business Incentive: reducing operational friction, ensuring Data Integrity through the Asset Administration Shell (AAS), and enabling Automation through technologies such as Module Type Package (MTP). This interactive forum provides the real takeaways and next steps needed to move your organization from isolated data silos to a high-impact, federated ecosystem. This is not just a Unified namespace.
Key Takeaways:
•Cross-Industry Intelligence: Lessons from industries like Steel, and Construction on federated data sovereignty.
•The ROI of Openness: How a holistic "Plug & Produce" integration slashes tech-transfer times and costs.
•Integrity & Resilience: Scaling ALCOA+ standards across decentralized supply chain partners along the pharmaceutical product lifecycle.
•Next Steps: Practical Proof of Concept /PoC frameworks and reference models to start your PODS journey.
Data exchange is no longer just a technical goal; it is a survival strategy for a resilient supply chain as well as eliminating manual and error prone process steps to ensure patient safety. In this interactive forum, we move beyond the "if" and into the "how" in a regulated pharmaceutical environment. We compare Pharma's progress to breakthrough successes in industries like steel manufacturing and Construction sectors (from building facades to digital twins) to see how open data drives radical resilience. This session explores the Pharma Open Data Space (PODS) as the essential enabler for the next generation of R&D and manufacturing. We bridge the gap between vision and reality by examining what is happening outside Pharma - learning from the interoperability of the other industries - and showcasing how leaders are already implementing these frameworks. Learn how to maintain 100% data ownership while enabling seamless, secure collaboration with CDMOs and suppliers, without drowning in Excel, Word and PDF files. We will dive deep into the Business Incentive: reducing operational friction, ensuring Data Integrity through the Asset Administration Shell (AAS), and enabling Automation through technologies such as Module Type Package (MTP). This interactive forum provides the real takeaways and next steps needed to move your organization from isolated data silos to a high-impact, federated ecosystem. This is not just a Unified namespace.
Key Takeaways:
•Cross-Industry Intelligence: Lessons from industries like Steel, and Construction on federated data sovereignty.
•The ROI of Openness: How a holistic "Plug & Produce" integration slashes tech-transfer times and costs.
•Integrity & Resilience: Scaling ALCOA+ standards across decentralized supply chain partners along the pharmaceutical product lifecycle.
•Next Steps: Practical Proof of Concept /PoC frameworks and reference models to start your PODS journey.
1330 – 1500
1500 – 1545
1545 – 1615
Regulatory and Quality
Alex Mbonye, National Drug Authority, Uganda
The story of implementation of a robust and effective Quality Management System (QMS) remains fundamentally un-told across the globe. It gets worse in the Low to Middle Income countries. This session will delve into the WHY and How QMS should be a fundamental core inclusion in all regulatory processes of a functional Regulatory Agency. Often times, during the carrying out of the core regulatory functions like Licensing, Marketing Authorizations and Dossier Assessments, Regulatory Inspections, Vigilance and Clinical Trials Oversight, Quality Management Systems are often pushed to the peripheral. This presentation will make a case for why Quality should be pushed at the forefront; Why it brings about efficiency and consistent operations and ultimately leading to science based and patient centric decision making.
1545 – 1615
Sustainability & Substances of Concern
Matt Popkin, PhD, GSK
Sustainable medicines and manufacturing: How do we build for the future in an uncertain world?
We live in critical and interesting times. Biomedical research continues to invent groundbreaking therapies and vaccines and advances in manufacturing technologies are providing new means to supply these. At the same time, industry is focused on making the manufacturing processes and supply chains of the future sustainable and economical, whilst supply chains the chemicals and raw materials needed to supply products are under pressure, often compounded by complex regulatory requirements. Concerns about animals, food and the environmental are increasingly restricting use of materials for medicines, and since 2025, where medicines are made has become a white-hot geopolitical flash point. Against all of this, medicines remain highly regulated such that implementing changes and technologies in manufacturing will require new thinking from innovators, regulators and legislators.
1545 – 1615
1545 – 1615
1545 – 1615
AI, automation, and cloud platforms are constantly getting better. This means that life sciences companies need to adapt how they build, test, and run their digital systems. But these same changes are making it harder to follow the old guidelines for GxP compliance. This presentation shows a Compliance-by-Design framework, which is a smart way to make sure that constructing AI-enabled systems includes quality, data integrity, and following the laws. This session demonstrates the application of GAMP 5 (2nd Edition), the GAMP AI Guide, and the Digital Validation Good Practice Guide in digital transformation initiatives, illustrated through practical examples from programs adhering to ISO 27701 and 27001 standards. It will teach you how to turn business and process needs into testable, risk-based requirements, establish data governance for AI that you can trust, and how to make sure that providers are responsible in models of shared responsibility. Participants will learn how to update compliance programs without blocking new ideas by ensuring that AI designs, automation, and validation methods are aligned with new rules. The presentation elaborates that compliance may be a strategic tool that helps digital maturity instead of standing in the way by bringing together quality, IT, and data science.
1615 – 1645
Regulatory and Quality
Jessica Helbling, University of St.Gallen
A series of over 60 in-depth interviews across the pharmaceutical and MedTech industries revealed that regulatory requirements are often perceived as one of the main barriers to continuous improvement initiatives. Many organizations experience ongoing tension between the regulatory mindset, focused on compliance, control, and risk avoidance, and the continuous improvement mindset, which emphasizes efficiency, agility, learning, and innovation.
This presentation will present how these mindsets interact, where they complement each other, and how companies can successfully overcome the perceived divide. Using real-world examples, we will show how organizations can create a culture where regulatory and improvement mindsets mutually reinforce long-term progress.
1615 – 1645
Sustainability & Substances of Concern
Ester Lovsin Barle, PhD, Takeda
Roger Ouimet, Agile GXP Advisors
This presentation will cover the high-level topics presented in the new ISPE Sustainability Guide, discussing how the Life Sciences industry can engage in sustainability, build sustainability culture and set goals. As we describe the benefits of sustainability and high-level examples of initiatives companies can take in achieving their sustainability goals, we will point attendees to the guide, the first publication of many more knowledge content submittals that the Sustainability COP is authoring.
1615 – 1645
GEP & GMP Compliant Project Delivery
Thomas Centner, PhD, Io-consultants GmbH & Co. KG
Jeremy Hotchkiss, Io-consultants GmbH & Co. KG
1615 – 1645
Pharma 4.0™ in Action
Martin Mayer, ZETA GmbH
Erik Hasenfus, Boehringer Ingelheim Pharma GmbH & Co. KG
We propose to present a real-world implementation of an AI Co‑Pilot for pharmaceutical operations, developed jointly by Boehringer Ingelheim, ZETA, and ANDRITZ. The Co‑Pilot offers natural‑language interaction for operators and engineers and connects engineering documentation, SOPs, and other curated records to deliver actionable guidance at the point of need.
Instead of having to manually search and retrieve data, this approach ensures rapid access to contextualized information for troubleshooting and decision support in the daily business of a pharmaceutical laboratory environment. In this session we will talk about our end‑to‑end journey – from data prep through secure deployment and operator onboarding – and share the experiences we’ve gained along the way.
1615 – 1645
1645 – 1715
GEP & GMP Compliant Project Delivery
1645 – 1715
Regulatory and Quality
Frank Seibel, Roche
Richard Lynch, SA Partners
Deviation management is one of the most visible, and often most frustrating challenges in pharmaceutical manufacturing. At Penzberg, deviation backlogs, lengthy investigations, and failure to drive to root cause were draining teams time and energy, with the potential to impact supply. Recognizing the need for change, the site launched a bold experiment to rethink deviation management. For one week, the team implemented flow, focusing entirely on executing effective deviation investigations. Leaders cleared their diaries to observe and coach, uncovering insights about capability, blockers, and the processes they were asking their teams to follow, learnings that would have otherwise taken a year to reveal. The use of digital and analytical tools further accelerated these insights, helping the team visualize patterns, identify root causes, and prioritize improvements with greater precision. Based on these learnings, the team designed a system that promotes faster, more effective resolution, addressing process, ways of working, escalation, tracking, and leadership support. The impact has been striking: shorter deviation closure times, fewer deviations per batch, problems solved right the first time, fewer repeat deviations, and a measurable boost in employee engagement.
1645 – 1715
Sustainability & Substances of Concern
Christian Lavarreda, Syntegon
Securing leadership support and funding for sustainability initiatives requires compelling business cases that align the environmental benefits with financial and strategic value. This presentation will provide practical guidance on crafting persuasive business cases for sustainability projects in pharmaceutical manufacturing. Drawing on the work of the Circular Economy sub-committee of the ISPE Sustainability Community of Practice (CoP) on this topic, we outline key elements that drive success, including lifecycle cost analysis, risk mitigation, regulatory alignment, and stakeholder engagement. Attendees will gain insights into quantifying sustainability benefits, integrating circular economy principles, and addressing common objections from decision-makers. Case studies will illustrate how well-crafted proposals can translate sustainability goals into actionable investments. Whether advocating for energy efficiency, waste reduction, or green chemistry initiatives, participants will leave with actionable strategies to strengthen their business cases and advance sustainability within their organizations.
1645 – 1715
In-silico supported development of the product and its control strategy (eg models used to define the shelf life, to identify dissolution safe-spaces to support specification setting and method development, systems models used to define process boundaries and identify CPPs and justify parametric established conditions) and used in control of the manufacturing process and its release (eg for Process Analytical technologies, or digital twin process models). Focus in this area has also been supercharged by the global emergence of control strategies based on ML and Agentic AI. Whilst these are real world enablers, that have also become watch points for regulation, especially following the publication in the EU of the new GMP Annex 22 on AI.
The speaker will represent the experiences of GSK and EFPIA companies in interactions with the EMA, FDA and other regulators on the use of modelling in development, and present a vision for how best to deliver a digital future.
1645 – 1715
Digital Compliance
Arun Parekkat, RiskCortex.Ie
John Patterson, Centenarian Technologies
The use of AI in GxP applications presents two key challenges: securing sensitive data and ensuring AI systems are properly managed to maintain GxP compliance. This presentation will feature a case study focused on approaches needed to identify and mitigating these and related risks when validating GxP systems, data assets and processes.
It will highlight lessons learned and explore further opportunities for improvement using advanced AI risk-based platforms in GxP CSV (Computer System Validation and CQV (Commissioning, Qualification, and Validation) settings. Additionally, the role of an Expert-in-the-Loop will be discussed, demonstrating how human oversight is essential for deploying such AI technology within a compliant, GxP framework.
1715 – 1900
0730 – 1730
Registration
0830 – 0845
0845 – 0915
General Session
Lars Petersen, FUJIFILM Biotechnologies
More than 2 billion people still lack regular access to medicine. To bridge this gap, biopharma must embrace the shift that other industries made decades ago: industrialization in manufacturing. Today’s model—where top pharma companies independently build facilities and run similar antibody production steps—creates costly duplication and inefficiency within the industry.
This keynote will explore how industrialization enabled by artificial intelligence and modularization modular design can reshape the biopharma landscape to accelerate global access. The keynote will highlight how FUJIFILM Biotechnologies has employed its kojoX platform, which standardizes equipment, processes, and procedures for faster facility builds and seamless tech transfers. By coupling modular construction with AI-driven autonomous process units throughout the factory floor, manufacturers can achieve “right-first-time” operations, boost asset utilization, and move closer to real-time release—delivering safer products more predictably, at scale.
Join the session to discover real-world examples of embracing industrialization to ensure uninterrupted access to medicine.
0915 – 0945
General Session
0945 – 1030
0945 – 1600
1030 – 1100
Digital Compliance
Iwona Ziobrowska, Accenture Nordics
Premkumar Iyangar, Accenture Solutions Pvt Ltd
This session explores how Artificial Intelligence (AI) technologies such as generative models and intelligent agents, are fundamentally transforming pharmaceutical validation workflows. Prem Iyangar will lead the discussion by outlining strategic considerations for AI readiness, including the importance of robust data integrity, traceability, and regulatory alignment in GxP environments. He will share practical examples of how AI-assisted documentation and automated deviation analysis can streamline compliance and improve efficiency. Complementing this, Iwona Ziobrowska will provide insights from real-world experience transitioning from paper-based to digital validation systems at a global regulated company. She will focus on the human factors that influence successful digital transformation, including tool selection, user adoption, and overcoming resistance to change. Together, the presenters will offer actionable guidance on selecting and adapting digital tools to support future AI integration, and share lessons learned from managing cross-functional collaboration. Attendees will leave with a strategic understanding of how to build digital foundations for AI-enabled validation, aligned with GAMP® and Pharma 4.0™ principles.
1030 – 1100
Sustainability & Substances of Concern
Kirsty Reid, EFPIA
1030 – 1100
1030 – 1100
Regulatory and Quality
Alfred Penfold, PM Group
In 2019 at an ISPE Global Regulatory Summit, the former FDA Commissioner Janet Woodcock MD is quoted as saying, "the pharma industry needs to embrace technology and ignite innovation." Over the past decade, the FDA has been true to its word and played a key role advancing new technologies such as continuous manufacturing. Similarly, the EMA Quality Innovation Group™ has been formed to help adopt new technologies. Learn how the FDA Emerging Technology Program and EMA Quality Innovation Group can help develop emerging technologies. The presentation ends with a case study on the next generation of aseptic filling technology, and how the collaboration with regulatory agencies can result in a more effective solution, with or without a sponsor on board.
1030 – 1100
Personalized and cell-based therapies are shifting life-science operations from product supply chains to time-critical, patient-specific services. In this model, performance is defined by coordination; any identity ambiguity or incomplete evidence can trigger rework, delay treatment, and increase compliance risk.
Across the sector, digital maturity efforts often stall because organizations focus on adding tools rather than establishing a shared operational backbone. What is needed is not just dashboard visibility, but actionable visibility: milestones, ownership, decisions, and evidence that move reliably across clinics, logistics, manufacturing, and QA/QP.
This presentation outlines an integration-first approach that connects existing enterprise systems and external partners without a "rip-and-replace" strategy, creating a case-centric digital thread from order to outcome. Participants will receive a leadership-ready blueprint for a staged rollout ("enhance before replace"), measurable success criteria, and practical patterns for using auditable AI assistance to accelerate triage and evidence packaging within governed workflows.
1100 – 1130
Regulatory and Quality
Nina Cauchon, PhD, Amgen Inc.
Pharmaceutical science is evolving rapidly with new therapeutic modalities and cutting-edge manufacturing techniques, and the challenge for sponsors is global harmonization of divergent regulatory expectations for innovation. Specific initiatives by the FDA (the Emerging Technology Program) and EMA (Quality Innovation Group) are helpful to provide perspective on perceived regulatory hurdles and to build a common understanding of what is needed to support innovation. Seeking feedback via these initiatives is valuable for sponsors, but having to navigate multiple international regulatory authorities and come up with a consolidated plan of action is not only time-consuming and expensive but discourages the pursuit of innovation. (reference: ISPE. Enabling Pharmaceutical Innovation: Delivering for Patients: Barriers to Innovation Survey Report (2024).)
There are ongoing pilot programs that utilize cloud-based platforms enabling real-time data sharing and collaborative multi-agency reviews for sponsor product applications, particularly post-approval CMC changes. The results from several sponsors are promising with considerable savings in approval timelines, and it is clear that the efficiency gains from these collaborative efforts benefit both industry and regulators. This session will explore the currently evolving landscape in pharmaceutical product innovation and how it can be aided by the use of real-time cloud-based data exchange.
1100 – 1130
Sustainability & Substances of Concern
Alessandro Viola, IPS-Integrated Project Services
Nitrosamines have emerged as one of the most urgent and complex contamination risks in Active Pharmaceutical Ingredients manufacturing. Once an underestimated topic in organic chemistry, they now represent a global regulatory challenge with direct implications for product safety, supply chain integrity, and patient trust. This presentation will explore recent scientific insights behind Nitrosamines formation, the evolving regulatory landscape, including the FDA's 2025 compliance deadline, and the practical strategies manufacturers must adopt to mitigate risk in the short term, and also in long term, preventing the implementation of future changes that may impact early assessments. Drawing on real-world examples and process engineering insights, the session will guide attendees through the multifaceted nature of Nitrosamines contamination, from raw materials and solvents to water systems. Attendees will leave with a deeper understanding of how to assess risk, implement safeguards, and prepare for future regulatory scrutiny for the ultimate benefit of the patient.
1100 – 1130
In the life sciences industry, maintaining GxP compliance while embracing digital transformation is a growing challenge. This presentation shares our journey of implementing a digital validation tool and leveraging automation to streamline Computerized System Validation (CSV) processes. By embedding compliance into the design of our systems and workflows, we accelerated project timelines, reduced manual effort, and ensured consistent data integrity all while remaining inspection ready.
We will explore how automation was applied to risk-based validation activities, how digital validation platforms supported acceleration and audit readiness, and how we aligned our approach with GAMP 5 Second Edition and the Digital Validation Guide. Real-world examples will illustrate lessons learned, including change management, and cross-functional collaboration.
1100 – 1130
GEP & GMP Compliant Project Delivery
Bruce Klopfenstein, GSK
The ISPE C&Q Baseline Guide, Volume 2 remains the industry gold standard for establishing a robust, risk-based Commissioning and Qualification (C&Q) program. Its approach—anchored in science- and risk-based principles—delivers efficiency, compliance, and cost-effectiveness throughout the C&Q lifecycle.
However, the Guide presumes that critical foundations are already in place: SOPs for risk-based execution, a defined system list, CQV resource planning, budget alignment, schedules, and supporting software tools. In practice, many projects stumble here, as these elements are often missing, incomplete, or addressed too late—causing avoidable delays and costly rework.
The CQV Early Engagement Checklist bridges this gap. It equips the CQV Project Manager to lead effectively during the project’s formative phases, ensuring that the CQV program is not only compliant but also set up for seamless execution once the ISPE methodology takes over. Early CQV involvement is increasingly recognized as critical to project success—this checklist makes that involvement practical and structured.
1100 – 1130
Pharma 4.0™ in Action
Jessica Mayne, Eli Lilly SA Irish Branch
This presentation offers a detailed case study of how Eli Lilly Limerick Next Generation Biotech (NGB) facility applies Pharma 4.0 principles to deliver a fully digital, paperless manufacturing environment. Central to this transformation is the strategic design and implementation of Electronic Batch Records (EBR), integrated with MES, automation platforms, and advanced analytics. Attendees will learn how EBR enables Right-First-Time (RFT) execution, robust data integrity, and regulatory compliance. The session will highlight holistic digitalization, operational readiness alignment, scalable multiproduct strategies, modular EBR design and change management frameworks to provide practical insights, proven methods, and valuable lessons learned from a digitally native greenfield biologics site.
1130 – 1200
Regulatory and Quality
Geert Vandenbossche, PhD, C&E Solutions BV
A steam-sterilized isolator has been designed and qualified to ensure that indirect product contact items are sterilized in line with Annex-1 requirements. The CIP/SIP approach used avoids cumbersome offline autoclaving and aseptic installation of bulky items. This presentation shares the challenges addressed in designing and qualifying the world's first steam-sterilized isolator. A key design feature is the pressure balancing system, which ensures a controlled pressure difference between the technical chamber and the process chamber of the vibratory bowl during all phases: steaming, cooling down, drying, and normal operation. At the same time, the integrity of all gaskets and silicone membranes was guaranteed. The steam-sterilized diffuser was evaluated during the same phases and documented for unidirectional flow. Overall, this innovative approach has proven its effectiveness. Steam-sterilized isolators are a breakthrough in aseptic processing and can be used in conjunction with VHP-sanitized lines.
In addition to the technical advancements, the project also focused on ensuring compliance with regulatory standards and industry best practices. The successful implementation of the steam-sterilized isolator represents a significant milestone in the field of aseptic processing, offering a reliable and efficient solution for sterilizing indirect product contact items.
1130 – 1200
GEP & GMP Compliant Project Delivery
Scott Slavens, Eli Lilly
Gilad Langer, Tulip
This presentation offers a unique look into Eli Lilly’s digital transformation journey, focusing on the adoption and global rollout of their frontline operations platform for compliant digital logbooks. We will trace how Eli Lilly shifted from paper-driven processes to a flexible, compliant, and scalable digital solution across multiple pharma manufacturing facilities. The session will highlight the stepwise approach taken by Eli Lilly to validate digital solutions in a GMP environment, ensure data integrity, and drive change management by empowering frontline teams. Attendees will gain actionable insights into key project milestones: from initial technology evaluation to pilot deployments, global rollout, and continuous improvement cycles. We’ll cover lessons learned around digital validation, compliance with data integrity standards, and how connected frontline apps have driven process optimization. The impact on operational excellence—including reduction of manual errors, real-time visibility, and enhanced audit readiness—will be backed by concrete performance data and qualitative frontline feedback.
1130 – 1200
Pharma 4.0™ in Action
Sebastian Härtner, Merck KGaA
Thomas Makait, MTP4Pharma® - Plug & Produce for Smart Manufacturing - Intrinsic Quality & Compliance
In this joint presentation, Dr. Sebastian Haertner of Merck KGaA, Darmstadt, and Thomas Makait of MTP4Pharma® will present a project that they carried out together. They will discuss the challenges they faced and the insights they gained from implementing the first commercial MTP-based modular plant in a GMP environment.
The presentation will highlight the challenges of implementing an integrated approach to computerized systems validation and the solutions to these challenges, including equipment qualification for modular plants based on the MTP standard. The presenters will explain how operations, engineering, quality assurance, commissioning, qualification, and manufacturing process validation should collaborate to leverage the benefits of MTP standards in a GMP environment. The steps to success include consistent data models spanning all trades, disciplines, organizations, and lifecycle phases, allowing for consistent, data-driven, and integrated engineering (process, plant/equipment, and automation), procurement, and construction. This approach leads to a smooth transition to computerized systems validation (CSV), including commissioning and equipment qualification (C&Q), and manufacturing process validation.
1130 – 1200
Sustainability & Substances of Concern
Sarah Sambolich, Abzena
In the current manufacturing practices of pharmaceuticals, regulatory bodies are responding to the heightened awareness of per- and polyfluoroalkyl substances (PFAS) utilized in these products. Although PFAS are acclaimed for their resistance to heat, water, and oil, their molecular structure presents a double-edge sword in medicine. PFAS all possess a long carbon chain bound to fluorine atoms and hydrophilic functional groups at the terminal end. The carbon-fluorine bonds present are highly resistant to bond breakage; enabling PFAS to resist breakdown and bioaccumulate in vivo (National Institute of Environmental Health Sciences, 2025). One approach to mitigate this is to redesign PFAS backbone by replacing the electron-withdrawing fluorine atoms with similar groups such as esters, amides, nitro, or cyano groups.
1130 – 1200
Digital Compliance
Phil Jarvis, No Deviation
Mark Drinan, Takeda Pharmaceuticals International AG
The presentation will be designed to go through the key aspects of the digital validation good practice guide and the overlap between aspects of the Validation 4.0 GPG , and will discuss how to go from a document centric approach to a data centric approach using emerging technologies to achieve validation 4.0 aims and generate greater efficiency in the use of digital validation tools (DVTS).
1200 – 1330
1330 – 1400
GEP & GMP Compliant Project Delivery
In response to evolving global market dynamics and geopolitical shifts, pharmaceutical companies are increasingly prioritizing domestic manufacturing capabilities. This trend is driving the need to duplicate GMP-compliant manufacturing facilities in multiple regions, particularly across Europe and the United States.
This presentation will explore how PM Group partnered with a client to successfully replicate a GMP Drug Substance facility originally designed and built in Ireland for implementation in the USA. We will share key insights into the challenges and strategies involved in creating "sister" facilities across different regulatory environments.
The session will focus on critical design considerations unique to the U.S. context and how they compare to European standards. Topics will include (but are not limited to):
Electrical rooms and equipment,
HVAC systems
Fire safety and egress requirements
Building envelope/enclosure design
Sustainability and environmental factors
Attendees will gain a deeper understanding of the technical, regulatory, and logistical nuances involved in facility replication across international borders—and how to navigate them effectively.
1330 – 1400
Sustainability & Substances of Concern
Dijana Hadziselimovic, STERIS Corp
Strategic changes to a legacy cleaning approach results in a more sustainable process
Validated cleaning approaches, especially legacy processes, are challenging to modify. To make the case for change, strategies such as the use of digital twins and continuous monitoring enable return-on-investment calculations and real-time quality assessment to mitigate risk. Embracing these strategies is a means to drive out waste and improve the overall cleaning process. The authors explored the elimination of a water rinse and blow down following the caustic wash step, examining the potential safety considerations, the effect on the quality of the cleaning process, and the potential benefit of implementing the change.
To investigate these concerns, it is important to know the exact chemical formulation of both caustic and acid cleaning agents. The physical properties of the acid rinse solution were assessed with temperature and pH checks, using different ratios of caustic and acid solutions. The volatile chemicals were assessed using gas chromatography with mass spectrometry (GC–MS). The cleaning and rinsing of the caustic cleaner, followed by the acid cleaner was also investigated using 304 stainless-steel coated surfaces.
1330 – 1400
Digital Compliance
Anna Dachs Soler, AMBIT Iberia
Francesc Garrido, AMBIT Iberia
Ensuring data integrity has long been a core GxP expectation, yet the transition to increasingly digital, cloud-based, and AI-enabled environments has made it more complex and more critical than ever. This session shares real-world lessons from a large-scale Data Integrity (DI) program currently being implemented in a global pharmaceutical organization preparing for FDA inspection.
Rather than focusing on theory, the presentation will explore how practical actions from governance and process redesign to system remediation and cultural change can embed integrity by design. The speakers will discuss key challenges such as balancing compliance with operational agility, defining ownership across QA and IT, and driving change through meaningful training and communication.
This collaborative session will highlight what worked, what didn't, and how teams can leverage GAMP 5 Second Edition and ISPE Data Integrity by Design guidance to move from reactive compliance to a proactive, sustainable model.
The goal is to inspire open discussion and shared learning across the ISPE community, fostering practical approaches that strengthen both compliance and business value.
1330 – 1400
Pharma 4.0™ in Action
Mihaela Simianu, SmartSkin Technologies
David Zouggagh, Sanofi
Experience and be inspired by "Why" and "How" Sanofi and SmartSkin Technologies are advancing pharmaceutical manufacturing through the strategic integration of Pharma 4.0 principles and SmartSkin™'s Digital Container Twins. This presentation will feature real-world case studies and examples, demonstrating how advanced Digital Container Twins, IoT connectivity, and modern learning systems are enabling real-time, reliable plant operations and data-driven decision-making. David Zouggagh, MST Engineer at Sanofi, will share his direct experience in establishing systems to gather, analyze, and evaluate outcomes. A key highlight will be a compelling case study highlighting a >30x reduction in defects for syringe product presentations, achieved through the application of Digital Container Twins. Attendees will gain actionable insights and practical strategies to replicate these impressive results in both pre-commercial and commercial manufacturing lines and products.
1330 – 1400
Regulatory and Quality
Stuart Finnie, Gilead Sciences
The post-approval change management protocol (PACMP) has become one of the more established tools introduced by ICH Q12. Many regions now either accept PACMPs or are looking to introduce PACMPs into their regulatory toolbox. It has also been used as a cornerstone of the collaborative review pilot initiated by ICMRA. Although a tool which has become familiar, the PACMP is not without its complexity. One misconception is that this is simply a protocol and, as such, a list of tests and standards. In fact, the PACMP is an exercise in the management of risk in the context of a proposed change. Elements of risk management and risk assessment are woven throughout the document and are essential to allowing an appropriate understanding of the proposed change. The final position of approval of a PACMP is essentially an example of risk-based decision making, where an agreement is reached that the risk of the change to impact the patient can be considered managed, provided that the agreed testing protocol is met. The importance of risk assessment and communication in the PACMP is discussed here along with proposals for appropriate PACMP authoring strategies to streamline global regulatory acceptance.
1400 – 1430
Regulatory and Quality
Andrea Kurz, F. Hoffmann-La Roche Ltd in Basel
This presentation illustrates the power of data. It shows how GMP/GDP inspection data contribute to collaboration in inspections towards the overall goal of inspection reliance. EFPIA has surveyed its member companies globally for more than 20 years building a rich inspection data set from which the key results are published annually and shared with regulators and other key stakeholders including opportunities to enhance inspection practices and gain efficiency through a better risk-based approach. Conclusions drawn from this data showcase examples where inspection reliance has been realized and helps to identify further opportunities for reliance on a global scale.
1400 – 1430
Pharma 4.0™ in Action
Milad Jami, NN
Joachim Toftegaard Hansen, Aerotak
Johan Nordling, Siemens Digital Industries Software
In the pharmaceutical industry, qualification activities are essential for safeguarding patient safety, product integrity and regulatory compliance. However, these activities can often be time-consuming and resource intensive. Today, advanced simulation and virtual engineering tools offer transformative support. They can be used in different stages of:
1.Early-stage conceptual design (support to risk analysis)
2.Design qualification and verification (support to design decisions)
3.Regulatory Qualification and validation (support to or replacement of physical tests in final qualification)
This presentation traces the complete journey of simulation in the domain and process of warehouses and intralogistics from early-stage layout design, risk analysis, to qualification and regulatory validation. It will showcase a real-world case study from Novo Nordisk, illustrating how Discrete event Simulation was used to design and optimize material flow and facility layout, and how CFD is now capable of supporting or even replacing physical temperature mapping in GxP-regulated areas. Attendees will learn about technical and organizational challenges, solution strategies, and the impact on patient safety and delivery speed. The session will highlight the integrated use of simulation tools to enable compliant, efficient, and resilient pharma warehouse and intralogistics operations.
1400 – 1430
Digital Compliance
Philip Hörsch, Vetter Pharma-Fertigung GmbH & Co KG
Kerstin Kruithoff-Ley, CirQum
The revised Annex 11 draft (2025) reinforces the role of audit trails as a key control to ensure data integrity and transparency in computerized systems. This session provides a pragmatic view on how to implement, review, and maintain audit trail functionality in compliance with GxP expectations. Real-world examples from regulated environments and systems (e.g. LIMS, ERP, laboratory instruments and manufacturing equipment) illustrate typical challenges, such as audit trail configuration, data volume management, change and/or manipulation detection, and long-term retention. Participants will gain a clear understanding of how to establish a risk-based, lifecycle-oriented approach to audit trail management that satisfies both regulatory requirements and operational efficiency.
1400 – 1430
GEP & GMP Compliant Project Delivery
Matthias Zelenka, VTU Engineering GmbH
Jasa Jeras, Sandoz
When Sandoz and VTU joined forces end of 2022 for a fast-track CAPEX project in Lendava, Slovenia, collaboration was more than a buzzword, it was the key to success. From concept design to ongoing site support, two cross-company leadership teams steered over 150 professionals spread across 15+ locations, led by the 2 presenters. This keynote will share how unconventional solutions, seamless teamwork, and a spirit of true partnership turned immense pressure into breakthrough progress. We'll explore what makes client engineering collaborations thrive, how process engineers can evolve into package owners, and why the right partnership model benefits everyone involved, even in a scattered supplier landscape.
1400 – 1430
Sustainability & Substances of Concern
Hans Stentoft, Novo Nordisk A/S
Paddy MacGabhann, Hyde Engineering and Consulting
Chasing sustainability initiatives has increasingly become an avenue for delivering improved productivity, while reducing the facility's carbon footprint through decreasing water and chemical usage and reducing or eliminating production waste streams. In the following presentation, we will show how our team has delivered substantial sustainability improvements through a focus on Clean-In-Place (CIP) Optimization within existing Pharma and Biopharmaceuticals facilities. We will share several specific optimization case studies and the resulting sustainability benefit in the manufacturing environment and some of the scientific and engineering principles that are core to the successful application of a CIP optimization program and the delivery of significant sustainability and productivity improvements.
1430 – 1500
Pharma 4.0™ in Action
Henrik Baran, Boehringer Ingelheim Vetmedica GmbH
This presentation will explore the journey of implementing a successful digital transformation program within a global BioPharma supply and operations organization over a two-year period. It will provide a comprehensive overview, starting from the initial mandate and assessment of the "as-is" state to the design of the "to-be" vision, securing executive endorsement, ramping up the program, executing the transformation, and ensuring long-term sustainability.
The presentation will provide actionable insights into how Pharma 4.0 principles were applied to create agile, data-driven, and connected operations realizing tangible benefits. Attendees will leave with an understanding of the challenges, possible solutions, and benefits of digital transformation in the BioPharma industry.
1430 – 1500
GEP & GMP Compliant Project Delivery
Rafael Beaus, Syntegon Telstar
1430 – 1500
Regulatory and Quality
Karim Kacimi, PhD, NovoNordisk
The International Council for harmonization (ICH) initiative brings together, since 1990, regulators and pharmaceutical industry to discuss scientific and technical aspects to achieve harmonized practice. Fourteen quality guidelines have reached implementation phase. Those guidelines play a key role in the preparation of any quality submission. ICH guidelines strengthened harmonization and reduced region-specific requirements. Nonetheless divergent interpretation of ICH quality guidelines across regulatory regions continues to present significant challenges to establish efficient regulatory strategy for post approval changes. This presentation examines how diverse interpretation of ICH quality guidelines, especially stability requirement, impact the planning and execution of post approval changes. Analysis of case studies will highlight operational and compliance risks associated with inconsistent guideline implementation.
1430 – 1500
Digital Compliance
Victor Bechmann, Kuatro Group
This presentation introduces the new GAMP AI Guide companion PE article "Seven Control Layers for Large Language Models" framework from the Jan/Feb 2026 GAMP issue, a GMP-aligned, risk-based approach to deploying LLMs for compliant automation. The theory is brought to life through a concrete use case: automated review of supplier engineering diagrams, including P&IDs, isometrics, and electrical drawings.
We present how each control layer contributes to trustworthy system behavior and how we have implemented or intentionally omitted specific controls to match business context, risk, and system maturity. Attendees will see how layered safeguards such as input filtering, domain-specific retrieval (RAG), structured outputs, model oversight, and explainability combine to form a defendable architecture aligned with the GAMP AI guide and EMA Annex 11/22 guidance.
1430 – 1500
Sustainability & Substances of Concern
Katarzyna Grudnik, Fluor S.A
Gregory Lepak, Fluor Life Sciences
Water is a vital yet often underestimated resource in biomanufacturing. Despite its essential role, its low cost frequently leads to underappreciation and missed opportunities for sustainable innovation. As sustainability becomes a core element of pharmaceutical production, the strategic management of high purity water used in cell culture, cleaning, and purification gains increasing importance.
This presentation explores the challenges of implementing water sustainability in Biopharma facilities. It introduces the 3R strategy: Reduce, Reuse, Recycle, as a practical framework for minimizing water use without compromising product quality.
The presentation proposes actionable opportunities in mammalian cell culture and microbial fermentation, to reduce net water consumption. It further includes water production systems and Cleaning In Place (CIP) operations, for sustainability action, which account for up to 40% of water usage in biopharma facilities. The insights presented are also relevant to other industries that rely on high purity water and CIP.
By showcasing real world applications of the 3R approach, the session aims to inspire facilities to identify water saving potential and implement tailored solutions. Sustainable water management supports environmental goals and enhances operational efficiency.
1500 – 1545
1545 – 1600
1600 – 1630
General Session
1630 – 1700
General Session
Syed Abbas Yar-Khan, Eli Lilly and Company
As demand for medicines accelerates globally, manufacturers face increasing pressure to scale aseptic operations without compromising quality, safety, or reliability. In this keynote, Abbas will share how a standardized, automated approach to aseptic manufacturing—replicated across a global network—enables consistent performance, reduced contamination risk, and faster delivery of critical medicines. Drawing on his extensive decades of experience leading large-scale sterile manufacturing networks, this session will explore the role of end-to-end automation, shared design principles, and cross-site learning in building scalable operations. Attendees will gain perspective on how one-team execution and disciplined replication support sustainable growth while maintaining the highest standards of product quality and patient safety.
1900 – 2300
Only included in the In-Person All Access Pass! Don't miss out on the chance to connect, indulge, and unwind at the ISPE Europe Annual Conference! Join us for an evening of connection and local flair at Madklubben Home of Carlsberg—a vibrant venue set within the historic Carlsberg Brewery in Copenhagen. Mix and mingle with colleagues while enjoying delicious food, refreshing beverages, and stories from the heart of Danish culture. With music, dancing, and a lively atmosphere, this event blends local history with great conversation and unforgettable networking opportunities.
0730 – 1700
Registration
0830 – 0835
General Session
0835 – 0845
0845 – 0915
General Session
0915 – 1015
🙂 – warm? sarcastic? neutral? forced? How do you interpret it — and how do you use it?
One tiny symbol, four completely different meanings. Across roles, genders, generations, cultures, and seniority levels, we all decode signals differently — and that’s where everyday misunderstandings begin. In this dynamic, interactive panel session, we explore why identical messages land in different ways depending on who receives them. An international, multi perspective panel will share surprising communication moments from their careers before we move into decoding exercises that make hidden interpretation patterns visible. You’ll leave with simple, practical tools to communicate more clearly, choose the right channel, and ensure your message lands the way you intend — in any team, in any context.
One tiny symbol, four completely different meanings. Across roles, genders, generations, cultures, and seniority levels, we all decode signals differently — and that’s where everyday misunderstandings begin. In this dynamic, interactive panel session, we explore why identical messages land in different ways depending on who receives them. An international, multi perspective panel will share surprising communication moments from their careers before we move into decoding exercises that make hidden interpretation patterns visible. You’ll leave with simple, practical tools to communicate more clearly, choose the right channel, and ensure your message lands the way you intend — in any team, in any context.
0945 – 1400
1015 – 1100
1100 – 1130
Digital Compliance
Darren Geaney, Kneat
Stefan Münch, Körber Pharma Consulting GmbH
AI capabilities are rapidly entering GxP workflows — from predictive maintenance and image analysis to LLM‑assisted documentation — and with them come new validation challenges. This session shows how to embed digital compliance by design from the ISPE Guidance perspective when AI is in scope, without turning projects into science experiments. We compare law vs. Guidance – the EU AI Act & the US AI/ML-Based Software as a Medical Device (SaMD) Action Plan (high‑level obligations, risk classification, transparency) versus ISPE/GAMP guidance (GAMP® 5 2nd Ed., GAMP® AI Guide, and the Digital Validation Guide) – and clarify where each applies. We then discuss what’s different about validating AI vs. traditional systems (the general CSV principles still apply) across lifecycle: data governance and integrity (ALCOA++), model risk assessment, selection of appropriate AI model, training/validation/test partitioning, explainability and HITL/“human‑in‑the‑loop”, change control and ongoing performance monitoring, and the use digital tools to support audit readiness. We close with a practical a case-led segment brings real-world experience: what the auditor asked, what artifacts mattered, and lessons learned.
•Compliance by design: Shows concrete techniques to integrate GxP controls early in AI projects (requirements, data lineage, risk‑based testing, monitoring).
•Guidance alignment: Translates key expectations from GAMP® 5 (2nd), GAMP® AI Guide, and the Digital Validation Guide into executable activities and artifacts.
•Data as a foundation: Demonstrates that trustworthy data (ALCOA++) is prerequisite for reliable AI — linking data governance to model reliability and audit defense.
•Regulatory clarity: Distills obligations under the EU AI Act and the evolving EU GMP landscape (Annex 11/15/22) into validation impacts and role/accountability matrices.
•Real‑world evidence: Körber’s practitioner view grounds the theory with what actually passed inspection and where teams struggle
1100 – 1130
Step 1 of the ICHM4(Q) revision is a landmark event, and ICH is not looking to the implementation of this, and the development of the guidance and tools for structured product quality submissions (SPQS) submissions. Both of these can now be considered in the light of the capability to automate the delivery using generative AI of CMC submissions and PQS documentation.
Linked to the this, the EU Commission and EU experts have been focused on the development of the new GPL Annex. The intent has been to enable innovation in manufacturing and the evolving quality requirements for the CTD. In addition, 2025 saw the publication in Europe of the updated variations regulations and guidance, also with the express intent of enabling innovation and change.
This session would seek to bring these threads together to assess how the dossier of the future can be used to deliver innovative products and manufacturing processes.
1100 – 1130
Pharma 4.0™ in Action
Dan Strange, Cellular Origins
Kevin Vela, Catapult Cell and Gene Therapy
Charles Heffernan, PM Group
As the industry advances toward agile, connected, and compliant operations, the cell-therapy sector faces an urgent need for scalable, cost-effective production models that maintain high product quality. This session presents a collaborative case study between Cellular Origins, the UK Cell and Gene Therapy Catapult (CGTC), and PM Group, demonstrating how next-level automation and advanced robotics within a CGMP environment can transform facility design, manufacturing execution, and operational excellence in ATMP production. The study showcases a modular robotic processing system that executes cell-manufacturing steps through closed, autonomous, connected workflows eliminating manual variability. Its plug-and-produce architecture integrates seamlessly with existing equipment platforms, supporting flexible, reconfigurable suites that can be scaled out or repurposed as demand evolves. The CGT Catapult contributes data from its Digital and Automation Testbeds—GMP-mirroring environments that reduce cost barriers to entry and enable developers to operate their manual biosafety-cabinet processes and robotic process in parallel, generating comparability data that support regulatory filings and de-risk technology adoption. PM Group provides data-driven facility and cost models quantifying reductions in labor, cleanroom footprint, and classification requirements. Together, these results show how robotic and digitalized operations improve consistency, compliance, and economics, paving the way for fleet-managed, distributed, and point-of-care manufacturing networks scalable globally.
1100 – 1130
SCHOTT Pharma Schweiz AG, in collaboration with CRB, has successfully transitioned from conventional multi-stage distillation to a membrane-based system for Water for Injection (WFI) generation setting a new benchmark in sustainable pharmaceutical water treatment. The continuous 24/7 demand for hot WFI to supply washing lines served as a key design driver, prompting a solution that balances operational efficiency with regulatory compliance. CRB supported the phased implementation strategy, ensuring full system redundancy and alignment with GMP standards. The concept integrates thermal sanitization and advanced heat recovery, contributing to both reliability and sustainability. Operating data demonstrates significant gains in energy efficiency and a measurable reduction in carbon footprint, underscoring the environmental and economic advantages of membrane-based WFI production.
1100 – 1130
GEP & GMP Compliant Project Delivery
Anne Magee, Eli Lilly
We will present a risk Assessment model for assessment of Leaks (breeches) in a closed system. Are we discarding batches unnecessarily? What is the RISK? We will present an in-depth risk analysis concerning contamination resulting from leaks in single-use and stainless steal systems within biopharmaceutical manufacturing. The central aim is to demonstrate that a leak does not inherently mean a product is compromised, allowing for alternative actions like reprocessing rather than immediate discarding. The methodology comprehensively evaluates the overall contamination risk level by assessing four key factors: Impact (Severity), Likelihood (Probability), Mitigation Measures, and Detectability. Crucially, the document proposes a quantitative model to calculate the likelihood of contamination, distinguishing between the probability of an external microorganism reaching the leak (Hit Probability) and entering the system (Ingress Probability), which is heavily influenced by pressure differences.
1130 – 1200
Pharma 4.0™ in Action
Magnus Liisberg, Omron
Christian Paaske, Xellia
Stefan Jensen, Optipeople
By tapping into real-time data from our manufacturing equipment and securely processing it in the cloud, we've built a predictive maintenance model that helps us get the most out of our assets while reducing downtime. This shift, inspired by Pharma 4.0 principles, has not only improved our operational efficiency but also helped us cut waste and stay compliant in a highly regulated environment.
In this session, we'll walk you through our journey, from the technical architecture and data flow to the change management strategies that made it all possible. It's a real-world example of how smart manufacturing can deliver tangible business value in the pharmaceutical industry.
1130 – 1200
GEP & GMP Compliant Project Delivery
Viral Segregation and risk of Viral contamination is often one of the most hotly debated topics in facility design. To have a wall between pre and post viral, do we need separate AHU, where should we put that wall… all questions that are often hotly debated. In this presentation we will present a novel framework for viral safety in biopharmaceutical manufacturing, developed in response to the challenges highlighted by the COVID-19 pandemic. This approach replaces traditional viral safety strategies with a comprehensive but simplified "layers of protection" model that uses Fault Tree Analysis (FTA) to precisely characterize contamination risks. The FTA method breaks down every conceivable failure mode into three essential components: the Viral Source, the Transfer Mechanism, and the Ingress Point. By employing a semi-quantitative risk assessment model, the framework systematically scores the preliminary hazard of these failure modes and then applies targeted Source and Route Controls to mitigate residual risk, demonstrating the value of robust controls, particularly closed systems as the best route for Viral Segregation.
1130 – 1200
Regulatory and Quality
The pharmaceutical industry's digital transformation is reshaping CMC, especially for new modalities, advanced manufacturing, and modeling. To ensure next generation medicines reach patients globally, greater collaboration among Health Authorities is essential.
This session spotlights the ISPE Project PRISM CMC use case and a practical path to collaborative review. Project PRISM leverages Precision FDA, a secure cloud platform that supports research and collaboration between regulators and industry. The environment is established and operational, tested with sponsors and multiple regulators through PRISM. It enables real time collaboration among FDA, sponsors, and other authorities, providing centralized access to structured data, shared tools, and auditability for all parties.
The session will feature demonstrations of end to end workflows and a CMC use case in a secure, collaborative cloud environment. We will show how structured CMC submissions and AI enabled tools can streamline review, and improve transparency by enhancing regulatory agility and potentially accelerating access of innovative therapies for patients.
1130 – 1200
Digital Compliance
Dori Gonzalez-Acevedo, ProcellaRX
Stephen Ferrell, Valkit.Ai
The next evolution in GxP compliance isn't documented, it's performed. This session redefines assurance through Digital Compliance by Design, integrating the principles of the ISPE GPG: Digital Validation, GPG: Artificial Intelligence, and GAMP® 5 Second Edition. By shifting from static SOPs to intelligent, agent-driven automation, regulated organizations can achieve continuous, explainable, and risk-based compliance. Drawing on practical implementation experience and ISPE guidance, the session showcases how agentic systems operationalize regulatory intent, enabling self-governing, auditable compliance aligned with CSA, ICH Q9(R1), and AI ethics frameworks.
Across the regulated landscape, organizations are struggling to reconcile the pace of digital transformation with traditional, document-heavy compliance structures. As highlighted in the ISPE GPG: Digital Validation, validation must evolve from retrospective documentation to living assurance. When combined with the principles of GAMP® 5 (Second Edition) and the emerging ISPE GPG: Artificial Intelligence, this evolution converges on a singular concept Digital Compliance by Design.
1130 – 1200
Sustainability & Substances of Concern
Fritz Roeder, Merck Healthcare KGaA
The presentation explores strategies for achieving CO₂ neutrality in pharmaceutical manufacturing by focusing on HVAC, clean utilities and other energy-intensive processes such as cleaning or sterilization. It emphasizes practical steps for reducing carbon footprints through HVAC optimization, lifecycle CO₂ analysis, and also includes use cases from industry. Additionally, the session highlights challenges and benefits of a transition to green energies.
1200 – 1230
Pharma 4.0™ in Action
Gianpaolo Orlandi, Wood Italiana
Peter Carydias, Transformation Wood - Digital Consulting
Pharmaceutical operators face pressure to reduce COGS and accelerate time-to-market under strict GxP compliance. While Pharma 4.0 transformation is mandated, 75-80% of digital initiatives fail to deliver value, posing significant investment risk in a regulated environment.
To address this, we introduce a quantitative 7-step methodology that de-risks digital investment by embedding value-realization and compliance-by-design into strategic planning:
1.Digital Maturity & Pain Point Assessment
2.Value Driver Identification
3.Base Case Value Tree Development
4.Initiative Impact Assessment
5.Quantitative Risk & Value Modelling
6.Feasibility & GxP Compliance Scoring
7.Portfolio Prioritization and Selection
This approach provides a roadmap to move beyond technology-first thinking. By applying quantified value modelling, organizations can build a robust business case for their Pharma 4.0 journey, ensuring investments are compliant, strategically aligned, and deliver measurable operational excellence.
The framework supports opportunities evaluation, creating a risk-adjusted portfolio of selected initiatives, including bespoke robotics for aseptic assembly, AI-driven predictive maintenance on critical equipment, and a GxP-aligned digital twin for operator training and process simulation.
1200 – 1230
Regulatory and Quality
Stuart Finnie, Gilead Sciences
Finding better and more predictable ways of managing the lifecycle of pharmaceutical products has been a constant search for industry and regulators over at least the last two decades. Efforts toward simplification have proved challenging, though efforts continue and new ways are evolving all the time. We aim to shine a spotlight on CMC lifecycle management, giving industry and agency views and discuss initiatives to improve matters. Ultimately, effective global harmonization in this area benefits everyone, reducing the burden on regulators, facilitating innovation and supply critical changes and ensuring the supply to patients.
1200 – 1230
Back to the Roots
Misunderstandings of What GAMP 5 Is About
Industry vs. regulatory authorities
GAMP is often viewed only as a software‑categorization tool. Many companies are hesitant to change long‑standing processes, even when GAMP practices encourage improvement.
Regulators often do not accept current GAMP interpretations—for example, around electronic signatures in GxP, cloud solutions, and their qualification.
This section will highlight common misunderstandings and discuss how these gaps can be addressed.
Can GAMP 5 Reduce Validation Efforts?
Real‑world examples of what can go wrong and how these issues can be improved.
What a Risk‑Based Approach Is—and What It Is Not
Practical examples of risk assessments, concluding with how these approaches impact patient safety and product quality.
Compliance vs. Critical Thinking (To Be or Not To Be)
What “compliance” truly means and how to foster critical thinking.
Real‑world examples—both ineffective and effective.
The “And If the Inspector Asks…” Veto
Why this mindset stifles innovation.
How explainable compliance can shift organizations toward becoming enablers rather than blockers.
1200 – 1230
GEP & GMP Compliant Project Delivery
We will present an industry-consensus guidance for evaluating and qualifying the interchangeability of single-use components (SUCs) in biopharmaceutical manufacturing. The presentation will be based upon the recent BioPhorum publication which establishes standardized definitions, methodologies, and criteria for assessing changes to SUCs to address supply chain vulnerabilities, particularly those highlighted during the coronavirus pandemic. It details an interchangeability evaluation methodology based on assessing fit, form, and function, categorizing changes into four groups from 'identical' to 'functional modification'. Furthermore, we will discuss supply chain aspects such as proactive and reactive approaches to interchangeability, as well as the commercial and operational perspectives of suppliers. Ultimately, the presentation will aim to support supply chain resilience and provide a risk-based approach for qualifying substitute components to ensure manufacturing continuity.
1200 – 1230
Sustainability & Substances of Concern
1230 – 1400
1400 – 1415
General Session
1415 – 1445
General Session
Tala Fakhouri, PhD, MPH, Parexel International
1445 – 1615
General Session
1615 – 1630
General Session
Skip the guesswork. We've curated three targeted agendas designed to maximize your conference ROI and deliver real Monday-morning impact, not just inspiration.
Choose your agenda based on where you are in your pharma journey:
Perfect for professionals new to pharma, career-changers, or anyone building foundational knowledge in pharmaceutical manufacturing.
Built for managers implementing technologies, leading teams, and solving complex operational challenges daily.
Designed for executives shaping enterprise-wide transformation and industry-wide innovation strategies.
Each agenda includes decision-making guidance for every time slot, so you'll know exactly why each session matters to your role and goals.
Speaker Qualifications
Speakers selected to present at ISPE events are leading professionals in their fields. However, it may be necessary to make substitutions. Every possible effort will be made to substitute a speaker with comparable qualifications. Every precaution is taken to ensure accuracy. ISPE does not assume responsibility for information distributed or contained in these events, or for any opinion expressed.
Agenda Changes
Agenda is subject to change. Last minute changes due to functional, private, or organizational needs may be necessary. The event organizer accepts no liability for any additional costs caused by a change of the agenda.