Call for Proposals

Cloud platforms, artificial intelligence (AI), and automation are changing how GxP-regulated companies develop, validate, and operate computerized systems. These technologies open real opportunities - and create new risks and responsibilities. To succeed, quality cannot be inspected in; it must be built in by design - integrated into processes and systems from the start. And it must be demonstrated: GxP regulations require documented evidence, appropriate to risk - not paperwork for its own sake. Where AI supports GxP processes, meeting the compliance baseline is no longer enough: the goal is demonstrable credibility - trust that a system is fit for its intended use, and that its results can be relied upon for the decision at hand.

Technology is evolving faster than written guidance can follow; what remains stable are risk-based principles and critical thinking. This topic will explore how GAMP principles, digital validation, and AI - from classic machine learning to generative models - can be applied effectively in regulated environments, enabling innovation without compromising GxP compliance. A special focus is data as the foundation for AI: without data quality and data governance, AI systems cannot function reliably - let alone in a regulated context. Data integrity is not only a compliance requirement but the cornerstone of responsible and effective AI use. Equally central is the human dimension: as automation and AI take on more of the work, accountability for the outcome stays with people. Oversight that merely confirms what a system has already produced creates an illusion of control - real oversight requires the competence, the information, and the authority to question a result, and it must be designed into the process rather than appended as a final signature. Credibility does not end at go-live: models drift, data changes, and oversight must follow the system into operation. Meaningful human oversight, clear intended use, and the ability to reconstruct how a result was reached are what turn compliance into credibility.

This topic is an open invitation to the field: if you have implemented, audited, or overseen these approaches in practice, we want to hear from you. Regulators, industry professionals, and solution providers alike are invited to submit proposals. Case studies and first-hand experience are especially welcome - including what did not work and what you would do differently today.

Suggested presentation topics:

• From Compliance to Credibility - Applying GAMP 5 Second Edition: Critical thinking, risk-based approaches, and documented evidence in real digital projects - what it takes for results to be relied upon for the decision at hand
• Verifying AI Models, Validating AI-Supported Systems - and Keeping Them Reliable in Operation: Getting the object of evidence right, and managing model drift, monitoring, and retraining after go-live
• Generative AI and LLMs in GxP: Guardrails, use cases beyond classic machine learning, and what makes generative systems different to control and to oversee
• Data as the Foundation for AI - Governance, Quality, and Integrity: Ownership, lifecycle, and ALCOA++ thinking for the data that trains, feeds, and leaves AI systems
• Meaningful Human Oversight Instead of the Illusion of Control: Designing oversight into AI-supported processes - beyond the final signature
• Digital and AI Use Cases Across the GxP Disciplines - from Lab to Launch: Experiences from GLP, GCP, GMP, and GDP - what transfers between the disciplines, and what does not
• Compliant Under Continuous Change - Cloud, Agile, and DevOps: Shared responsibility, test automation, and the validated state as a moving target
• The Supplier Side - Audits and the Provider Perspective: Auditing suppliers of AI-enabled systems, and how vendors and hosting partners support their customers' compliance (providers are expressly invited to present)

The pharmaceutical industry is constantly adapting to new market dynamics, scientific advancements, and operational demands. This content area provides an opportunity to explore forward-looking developments and transformative ideas that are shaping the future of pharmaceutical engineering. Presentations may spotlight innovations in how we design, build, operate, and support facilities and supply chains, as well as how we attract, develop, and retain the next generation of industry talent.

Potential topics include:

• Workforce Development & Skills of the Future: Exploring strategies to develop digital fluency, upskilling, and reskilling for human-machine collaboration, non-traditional workface pathways, and creating work environments centered on product and patient outcomes.
• New Manufacturing Trends: New processing methods, production models, and operational strategies transforming pharmaceutical manufacturing
• Supply Chain Resilience & Optimization: Innovative sourcing, logistics, and inventory models which improve agility and reliability in global pharmaceutical supply
• Disaster Recovery & Operational Resiliency: Strategies for rapid recovery and continuity of operations following natural or manmade disasters and other critical events
• Market-Driven Adaptations: Industry responses to shifting therapeutic demand, patient access expectations, and global healthcare trends
• Cross-Sector Inspiration: Lessons and tools borrowed from other industries which may be applied to pharmaceutical engineering
• Current Industry Challenges: Pressing issues affecting sites and organizations today, and approaches to address them
• Proposals which may not fit under the other categories are also welcome.

This area, focused on Good Engineering Practice & Efficient Investment, is dedicated to exploring the planning, execution, and regulatory compliance of engineering projects in the pharmaceutical and drug-substance biopharmaceutical sectors.

Presentations should foster an interactive and collaborative environment through case studies, lessons learned, and engaging discussions. Proposals offering practical insights, novel solutions, and a strong focus on real-world applications are particularly welcome.

Proposals should provide practical insights, novel solutions, and real-world applications in:

• CAPEX Project Showcase: Sharing recent facility projects, detailing the design process, project execution, and key learnings
• Engineering Project Management Excellence: Strategies and tools for efficient capital expenditure, project governance, and project management – including risk mitigation, and cost and schedule optimization
• Impact of New Guidelines on Facility Design: Interpretation of guidelines, how they impact facility design and operations, and ways to effectively implement a risk-based approach
• Advanced Tools: Explore the application of digital tools such as AI and digital twins to enhance engineering quality and efficiency
• Navigating GMP Compliance Facilities, from Design to Realization: Address strategies for managing compliance in a changing regulatory landscape, and interacting with regulatory agencies throughout a project's lifecycle
• Future Facility Construction & Design: Innovations, challenges, and solutions in the design, construction, and qualification of GMP-compliant facilities, and ways to integrate process, digitalization, sustainability, and compliance

The pharmaceutical industry is experiencing unprecedented growth and opportunities transforming pharmaceutical science and manufacturing. New technologies, such as artificial intelligence (AI), machine learning (ML), and advances in automation are generating interest in many areas of development and CMC. These innovations are fundamentally reshaping the pharmaceutical industry’s future. When combined with growing platforms such as Biotech, Advanced Therapy Medicinal Products (ATMPs), Antibody Drug Conjugates (ADCs) and Radiopharmaceuticals, there are many complex challenges being addressed by innovative technologies and solutions. It is more important than ever to collaborate and share opportunities which have the potential to redefine manufacturing and operational excellence.

Submissions and case studies may include:

• Biotech
• ATMPs including mRNA and CAR-T
• Antibody Drug Conjugates (ADCs)
• Radiopharmaceuticals
• Continuous Manufacturing
• Modular / Point of Care Manufacturing
• Multi-product / Multi-modal facilities
• Technology Transfer
• Operational Readiness

This content area provides a strategic and practical overview of how digital technologies are reshaping pharmaceutical manufacturing. As the industry advances toward more agile, connected, and data-driven operations, thought leaders and innovators will share insights and applied case studies demonstrating the value of digital transformation across the product and facility lifecycle.

Key topics include the integration of Pharma 4.0 strategies into facility design, construction and manufacturing, with a focus on ways digital technologies shape infrastructure and manufacturing planning, execution, and long-term adaptability. Plug-and-produce and data connectivity frameworks enabling seamless system integration and supporting intelligent, modular, and interoperable manufacturing environments will also be examined. Presentations may also cover the implementation of automation and advanced robotics to improve precision, reduce variability, and increase production throughput. In addition, emerging technologies such as digital twins and artificial intelligence will be explored for their roles in predictive analytics, real-time decision-making, and lifecycle management.

Through practical case studies, presentations attendees will share how leading organizations are successfully applying Pharma 4.0 principles to drive innovation, maintain compliance, and elevate operational performance. Sessions will provide actionable insights and a clear roadmap for implementing future-ready pharmaceutical manufacturing.

Key Themes:

• Innovative Facility Design and Manufacturing for the Future: Rethinking manufacturing layouts to support flexibility, scalability, and digital readiness
• Plug & Produce and Seamless Data Connectivity: Enabling modular, interoperable production systems through standardized interfaces and real-time data integration
• Next-Level Automation and Robotics: Leveraging autonomous systems and collaborative robots to enhance efficiency, consistency, and safety
• Digital Transformation with Advanced and Emerging Technologies: From edge computing to cloud platforms — unlocking new value chains and smarter operations
• Applied Use Cases: Digital Twins and AI in Action: Real-world applications demonstrating the impact of plug and produce, simulation, prediction, and optimization in pharmaceutical environment

The pharmaceutical industry is navigating one of the most significant periods of regulatory transformation in recent decades. Across Europe and globally, manufacturers are facing expanding regulatory expectations, accelerating technological innovation, increasing supply-chain complexity, and heightened scrutiny of product quality, data integrity, and patient safety.

In Europe, the EU Pharmaceutical Package will fundamentally reshape the regulatory framework governing the development, approval, manufacture, and lifecycle management of medicinal products. These reforms are intended to improve patient access, strengthen supply resilience, support pharmaceutical innovation, and enhance the competitiveness of the European life sciences sector. Alongside these legislative changes, the implementation of the EU AI Act and evolving GMP requirements including the revisions to Annex 11 (Computerized Systems) and the proposed Annex 22 (Artificial Intelligence) are creating new expectations for the governance, validation, and oversight of digital and AI-enabled systems across pharmaceutical operations.

Globally, regulatory authorities are also advancing new approaches to quality oversight and manufacturing resilience. The FDA continues to evolve initiatives focused on quality management maturity, advanced manufacturing technologies, supply-chain robustness, digital systems, and data-driven quality assurance. Across both FDA and EU regulatory frameworks, there is increasing emphasis on proactive quality management, risk-based decision making, contamination control, continuous process verification, data integrity, and the responsible use of artificial intelligence. Companies must now prepare not only for emerging regulations but also for a future in which regulators expect greater transparency, technological maturity, and demonstrable quality culture throughout the product lifecycle.

Drug shortages remain a critical challenge for healthcare systems worldwide, prompting increased regulatory focus on vulnerability assessments, shortage prevention plans, supply-chain visibility, and access to critical medicines. Regulators are seeking sustainable solutions that strengthen manufacturing resilience while ensuring continued product availability for patients. Industry case studies demonstrating effective shortage prevention, risk mitigation, supply-network redesign, and innovative manufacturing approaches are particularly encouraged.

Submissions may include:

EU Pharmaceutical Reform and Emerging Regulations

• New EU Directive replacing Directive 2001/83/EC governing authorization, labelling, marketing, and supervision of medicinal products.
• New EU Regulation replacing Regulation 726/2004, including EMA authorization procedures and governance.
• Impact of the EU Pharmaceutical Package on quality systems, manufacturing operations, lifecycle management, and regulatory compliance.
• GMP Chapter 4 – Pharmaceutical Documentation.
• Annex 15 – Qualification and Validation Concept paper -Revision
• EMA PQS (Pharmaceutical Quality System) Pilot and FDA Quality Management Maturity initiatives.
• New ICH Revisions- ICHQ3E (Extractables & Leachables) and ICHQ5E (Comparability of Biologics)

Digitalization, Data Integrity and Artificial Intelligence

• Annex 11 (Computerized Systems): implementation challenges and future expectations. Annex 22 (Artificial Intelligence): governance, validation, and compliance considerations.
• Data integrity, digital assurance, and computerized system lifecycle management.

GMP Compliance and Pharmaceutical Quality Systems.

• Annex 1 – Manufacture of Sterile Medicinal Products: implementation experiences and inspection trends, Contamination Control Strategy (CCS) development and execution. Annex 1 implementation in low-bioburden manufacturing environments.

Regulatory Harmonisation and Resilience

• Critical Medicines Act (CMA): implications for pharmaceutical manufacturing, supply-chain resilience, strategic manufacturing capacity, procurement, and security of supply within the EU.
• Drug shortage prevention, vulnerability assessments, and supply-chain risk management.
• Quality Risk Management (ICH Q9) applications and best practices.

Innovation and Advanced Manufacturing

• Advanced Therapy Medicinal Products (ATMPs) and evolving regulatory requirements,.
• Modular, decentralized, and point-of-care manufacturing.
• Extractables and Leachables
• Regulatory approaches to innovative technologies and advanced manufacturing platforms.

This topic addresses specific areas, compounds, or ingredients of concern in pharmaceutical manufacturing and supply chains, spanning across pharmaceutical manufacturing. Topics include industry and regulatory responses on:

• PFAS (Per- and Polyfluoroalkyl Substances): the status on research, and potential new regulations for the pharmaceutical industry and other areas (e.g. water and the environment)
• Ongoing discussions around the use of talc and other excipients
• Submissions on additional emerging issues drawing regulatory attention are also encouraged
• Nitrosamines

Like many industries, the pharmaceutical sector faces the challenge of industry growth while reducing its environmental impact. Progress has been made, but more change is needed to achieve sustainable and circular production. Proposals highlighting steps (large or small) toward sustainability, are encouraged, including decreased supply of raw materials without decreasing production; shifting to a more sustainability production method; waste reduction and conversion of waste to a useable resource; and methods and innovations reshaping the future of the industry.

Submissions may include:

• Building Technology and adaptability to climate change
• Reduce / Reuse / Regenerate / Reclaim
• Modular Production
• Continuous Manufacturing
• Multi-product / Multi-modal facilities
• Shared resources across companies — legal implications and solutions
• Waste handling and circularity
• Utility reduction (e.g. HVAC and WFI).
• Transport / Distribution
• Regulations
• Environmental authorization for new projects, biodiversity impact