Featured Topics

The life sciences industry is undergoing a profound digital transformation. Cloud-based platforms, AI-powered tools, and intelligent automation are reshaping how we develop, validate, and operate systems. These technologies bring tremendous opportunities — but also new risks, expectations, and responsibilities. To succeed, compliance must be embedded by design: proactively integrated into processes, systems, and technologies from the start.

This topic will explore how GAMP principles, data integrity, digital validation, and artificial intelligence (AI) can be applied effectively in regulated environments — enabling innovation without compromising GxP compliance. A special focus lies on data as the foundation for AI: without trustworthy, high-quality, and well-governed data, AI systems cannot function

reliably — let alone in a regulated context. Data integrity is not only a compliance requirement, but also the cornerstone of responsible and effective AI use.

Regulators, industry professionals, solution providers, and thought leaders are encouraged to submit proposals exploring modern compliance strategies, practical implementation experiences, and forward-looking perspectives. Submissions should include case studies and real-world applications; lessons learned from implementation and scaling; collaborative approaches between industry, regulators, and vendors; and insights into emerging technologies and future regulatory expectations.

Presentation Topics:

• Compliance by Design in Practice: Ways technologies such as AI, cloud, and automation, can be implemented while ensuring alignment with GxP and regulatory expectations
• Applying GAMP 5 Second Edition, the GAMP AI Guide, and the Digital Validation Guide: Real-world examples of how companies are integrating GAMP guidance into digital initiatives.
• Annex 11 vs. Annex 15 – Clarifying the Compliance Landscape: Understanding the intersection of computerized systems (Annex 11) and qualification & validation (Annex 15), and what this means for QA, IT, and project teams
• Data Integrity in the Digital Era: Ensuring traceability and trust across digital platforms, with a focus on Chapter 4. In the context of AI, data integrity is not just a requirement, but the foundation for reliable and compliant AI applications.
• From Process Requirements to System Requirements: Translating business processes and user needs into risk-based, testable, and GxP-compliant system requirements
• Supplier Qualification and Continuous Oversight: Managing compliance in outsourced and cloud-based environments – including the role of SOC 2 reports, shared responsibility models, and ongoing vendor monitoring
• Business Continuity and Disaster Recovery: Designing resilient and compliant systems, and preparing for failure scenarios in regulated digital infrastructures

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 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.

Presentations 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

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 EMA is preparing major changes to EU pharmaceutical legislation – commonly referred to as the “pharma package.” These reforms include replacing Regulation 726/2004 and Directive 2001/83/EC, with a goal of faster access to safe, affordable medicines; greater supply resilience; stronger innovation and competitiveness across Europe; and broader compliance with the EU AI Act (with major provisions expected August 2026, which will require transparent, trustworthy AI use in medical software and tools).

Presentations may address the impact these new regulations may have on pharmaceutical manufacturing operations, as well as focus on critical questions and the outcome of the commenting period for the updated Annex 11 “Computerized Systems” and Annex 22 “Artificial Intelligence.” The role of Large Language Models (LLM) in connection with Annex 22 may also be discussed.

Drug shortages continue to be a major issue in the pharmaceutical industry, with delays in patients receiving products. The EMA and National Competent Authorities have increased requirements for sharing information on drug shortages or potential drug shortages. Case studies on the implementation of drug shortage prevention plans and drug shortage mitigations plans are encouraged (for example, answer the question, “is repatriation of production to Europe a possible solution?”). Proposals discussing the interpretation of Annex 1 Aseptic Manufacturing, which is now in the implementation stage, are also welcome.

Key Topics:

• New Directive 192 replacing 2001/83 EC: union code governing authorization, labelling, marketing and supervision relating to medicinal products
• New Regulation 193 Q2 2026: procedures for authorization and supervision of medicinal products, and EMA governance
• GMP Chapter 4 Pharmaceutical Documentation
• Annex 11 Computerized Systems
• Annex 22 Artificial Intelligence
• Annex 15 Qualification Validation
• Drug Shortage Prevention

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)
• Titanium Dioxide: the European Commission’s decision on the use of compound in pharmaceutical preparations, and how this may influence the future
• Ongoing discussions around the use of talc and other excipients
• Submissions on additional emerging issues drawing regulatory attention are also encouraged

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.

Topics Include:

• Building Technology
• Reduce / Reuse / Regenerate / Reclaim
• Modular Production
• Continuous Manufacturing
• Multi-product / Multi-modal facilities
• Shared resources across companies — legal implications and solutions
• Waste handling
• Utility reduction
• Transport / Distribution
• Regulations