Conference Overview
FREE TO ATTEND FOR PHARMA AND BIOTECH
Kick off 2027 and set the tone for the year at 19th Annual PFS & Injectable Drug Devices Europe Conference!
Join us in London next January where we will unite leaders and innovators from the device development industry. This highly anticipated conference offers unparalleled opportunities to explore the latest advances in combination product technology, share insights, and foster collaboration across a dynamic three-day program.
Mark your calendar and be part of this must-attend event in January 2027. We look forward to welcoming you to London!
Conference agenda
Developing Successful Combination Products: Integrating Science, Engineering and Human Factors from Concept to Commercialisation
Aligning drug, device and human factors teams early to define product requirements, development strategy and regulatory expectations
Understanding how formulation, dose volume, viscosity and delivery requirements influence device design, testing and validation throughout development
Applying a holistic combination product approach, incorporating scientific justification, measurement strategies, manufacturing considerations and ISO 11608 requirements to support successful product launch and lifecycle management
Session Reserved for Sponsor
Why Regulatory Strategies Fail—and How to Win with Combination Product
Common strategy pitfalls
Align clinical, device, and CMC
Winning globally: FDA, EU, and beyond
Article 117: Key Challenges, Updates and Lessons Learned
Understanding evolving Notified Body expectations and recent regulatory guidance for Article 117 submissions
Addressing common challenges around data readiness, technical documentation, and GSPR compliance
Sharing practical strategies to streamline submissions, reduce delays, and improve approval predictability
Session Reserved for Sponsor - Suttons Creek
Panel Discussion: Future of Drug Delivery: What’s Next in Drug Delivery and Device Design?
Exploring next-generation delivery technologies beyond traditional PFS
Balancing innovation with cost, scalability, and real-world patient usability
Understanding how digital and material advancements will shape the future of device design
Session Reserved for Sponsor
Improving Health Outcomes Through Patient-Centric Design: Expanding Beyond the Physiological – The BEAMER Approach
Expanding the focus from purely physiological needs to a broader understanding of patient behaviours, motivations, and real-world challenges to improve adherence and health system efficiency
Introducing the BEAMER / B-COMPASS model and how behavioural insights can be applied to design more effective, patient-centred solutions
Demonstrating how shifting to human-centric design approaches can drive improved treatment adherence, better patient outcomes, and overall healthcare value
Panel Discussion: Advancing Quality by Design and Design Controls in Device Development
How are organisations strengthening the link between QbD principles and design control processes?
Best practices for improving collaboration, risk management,and development efficiency across teams
Building a stronger foundation for innovation, regulatoryreadiness, and product quality in combination productdevelopment
Integration of Quality by Design (QbD) and design controls in device development
Current State of the Industry: The BioPharma sector is advancing in its use of QbD and design controls, but maturity levels vary widely - highlighting gaps in how CQAs, control strategies, and design inputs are interconnected across organizations
Why Integration Is Important: Stronger integration between QbD principles and design control is essential to reduce development friction, enable clearer alignment across cross-functional teams, and create a more consistent foundation for device–drug combination product quality
Benefits of Integration: A unified framework and shared training can streamline development, enhance risk management, and improve regulatory readiness - ultimately accelerating innovation while supporting sustainability and robust product performance
Platform-Based Drug Delivery Development – Opportunities, Challenges and Future Directions
Sharing experiences and lessons learned from implementing platform-based device development strategies
Discussing how platform approaches can reduce development timelines, costs, and regulatory burden
Exploring the balance between standardisation, flexibility, and evolving patient and product requirements
Building Effective Collaboration Across Combination Product Development
Integrating pharmaceutical sciences, device engineering sciences, manufacturing, regulatory and user perspectives to support informed cross-functional decision-making
Building effective collaboration models that translate patient and product requirements into successful combination product development and commercialisation strategies
Identifying opportunities to strengthen collaboration and decision making as combination products become increasingly complex, data-driven and globally regulated
Utilising AI in Device Development – From Concept to Practical Application
Identifying where AI is already delivering value across design, testing, and manufacturing
Moving from experimentation to validated, regulatory-compliant use cases
Integrating AI into existing development workflows without increasing complexity
Chair’s Closing Remarks and Close of Focus Day
Building the Next Generation of Combination Products Through Platform Innovation
Applying platform-based thinking to streamline device development across multiple therapies
Enhancing collaboration between drug, device, and manufacturing teams throughout the product lifecycle
Overcoming technical and operational challenges when scaling device platforms for global markets
Session Reserved for Gold Sponsor - MGS
Notified Body Opinions for a Legacy Products, How Hard Can They Be?
Notified Body Opinions are now routine for new combination products, but are still relatively rare for legacy approved products.
What are the potential challenges and pitfalls associated with seeking a NBOp for a legacy approved product?
What best practices that may be applied to aid in a successful NBO process for a legacy product?
Session Reserved for Sponsor
Panel Discussion: Embedding Sustainability into Device Development
Integrating sustainability into design, regulatory strategy, and human factors, what’s changing in practice
Balancing environmental goals with usability, patient outcomes, and commercial viability
Moving beyond siloed “green” initiatives to fully embedded, cross-functional development approaches
Human Factors and Usability Challenges in Large-Volume Injection Devices
Addressing the unique usability challenges associated with high volume drug delivery
Applying human factors testing to optimise device design, instructions for use (IFUs), and labelling
Translating user insights into practical design solutions to support safe and effective product adoption
Session Reserved for Nemera
Device Development Strategy in Early Drug Development
Device strategy must start early: Decisions on formulation, presentation, and delivery platform made before or during Phase 1 can significantly constrain future device options and commercialization pathways
Define a device selection point before Phase 1: Early alignment across formulation, device, clinical, and manufacturing teams reduces the risk of costly late-stage changes, additional studies, or reformulation
Integrated planning reduces risk: Proactively evaluating device constraints and using parallel cross-functional development improves predictability, accelerates development, and increases the likelihood of commercial success
Driving Novel Device Development Through Platform Innovation
Applying platform approaches across pre-fi lled syringes, autoinjectors, and pen injectors to accelerate innovation
Balancing common device architectures with the need for differentiated patient experiences
Lessons learned from developing next-generation delivery systems across multiple product platforms
Navigating updates to ICH guidance for drug-device combination product content and understanding the impact on future regulatory submissions
Session Reserved for Credence MedSystems
Chair’s Closing Remarks and Close of Day One
Session Reserved for Haselmeier
Driving Sustainability in Drug Delivery Devices: From Ambition to Action
Embedding circular economy principles into the development, manufacture, and end-of-life management of drug delivery devices
Balancing sustainability goals with patient needs, regulatory requirements, and product performance
Exploring opportunities for collaboration across the value chain to reduce environmental impact and accelerate progress
Reducing Carbon Impact Across the Patient Care Pathway: Advancing Sustainable Drug Delivery Development
Measuring and reducing product carbon footprints through lifecycle assessment (LCA) and data-driven decision making
Driving sustainability through material innovation, circularity initiatives, and responsible device design
Improving patient outcomes and reducing healthcare burden through at-home administration and next-generation drug delivery devices
Driving Sustainable Packaging Compliance: Preparing for the EU Packaging and Packaging Waste Regulation (PPWR)
Understanding the impact of PPWR on pharmaceutical packaging design, materials selection, and lifecycle management
Leveraging industry collaboration, baseline waste data, and shared toolkits to support effective compliance strategies
Balancing packaging reduction, product protection, and patient needs while meeting evolving sustainability requirements across Europe
Session Reserved for DCA Design
EFPIA Perspective on Article 117: Lessons Learned and the Road Ahead
Reviewing key challenges and successes from five years of Article 117 implementation
Exploring industry expectations for Notified Body opinions, timelines, and regulatory alignment
Identifying opportunities to improve predictability, collaboration, and lifecycle management for integral drug–device combination products including emerging risk-based approaches
Chair's Closing Remarks and Close of Day One
Bridging the Gap: Ensuring Lab-Based Device Verification Reflects Real-World Use in 2027
Identifying where traditional lab-based and automated testing still fail to capture real-world user variability, edge cases, and human-driven failure modes
Integrating human factors, risk management, and regulatory expectations into next-generation verification strategies to strengthen evidence packages
Leveraging advanced simulation, digital tools, and user-informed test design to generate robust, regulator-ready data demonstrating real-world performance
Session Reserved for Gold Sponsor
Applying AI in Medical Device Development – Opportunities, Regulations, and Practical Lessons
Where AI Creates Value in Design and Development
From Chatbots to Intelligent Systems: AI Deployment Models
Regulatory and Quality Expectations for AI in Regulated Environments
Lessons Learned from Early AI Adoption
The Future of AI in Device Development: Opportunities and Challenges
Advancing Innovation in Injectable Device Development
Exploring key considerations for successful device
development across the product lifecycle
Balancing patient needs, usability, and technical
requirements in device design
Current and future priorities for Sandoz
Session Reserved for Sponsor
Panel Discussion: AI in PFS & Injectable Drug Devices: From Concept to Patient Impact
Where AI is already making a difference in device design, manufacturing, and quality
Practical use cases for AI across the PFS lifecycle, and where the limits still are
Keeping innovation patient centric: improving usability, safety, and outcomes while adopting AI
Combined Experimental and Computational Approach to Analyze Strain on Vials During Freezing
Frozen drug product storage can induce mechanical strain on glass vials, potentially causing vial breakage
A combined methodological approach – experimental strain gauge measurements and finite element analysis, was developed to systematically characterize strain formation during freezing
Key influencing factors (formulation composition, vial type, process parameters) were identified and effective strain-mitigating strategies derived
Session Reserved for Gerresheimer
Next-Generation CCIT: Robust Helium Leak Testing via ICH Q14 Principles
ICH Q14 Enhanced Validation Pathway: Establishes a comprehensive, deterministic validation pathway for quantitative helium leak detection by using multivariate Design of Experiments (DoE) to map a Method Operable Design Region (MODR)
Modular Microcapillary Positive Controls: Introduces highly adaptable, modular positive controls to systematically evaluate precision, specificity, and the limit of quantitation (LoQ)
Correction of Statistical Assumptions: Identifies distinct data heteroscedasticity across the test range, invalidating traditional homoscedastic Gage R&R models and establishing relative standard deviation (RSD) as the necessary metric for precision validity
Navigating Regulatory Change for PFS and Injectable Devices in the EU and UK
Key regulatory developments impacting combination products and device-led submissions
Interpreting evolving EU and UK requirements across the product lifecycle
Practical considerations for manufacturers during a period of regulatory transition
Session Reserved for Sponsor
EDDOs for SDD/mPFS and Control Strategy
Identifying and defining critical device performance parameters for single-dose devices or manual pre-filled syringes
Linking elemental device design outputs to verification, risk management, and control strategy across development and manufacturing
Ensuring consistent product quality and performance through robust control
Chair’s Closing Remarks and Close of Day Two
Human Factors as a Critical Strategic Asset: Leveraging prior Pre-filled Syringes Human Factors Data to accelerate Safe and Effective Drug Delivery
Leveraging Decades of Human Factors Knowledge by Understanding the Enduring Nature of Prefilled Syringe User Interactions
Moving Beyond Individual Studies: Leveraging Platform Human Factors Data and Use-Related Risk Knowledge from Established PFS Systems to Support Regulatory Confidence and Smarter Development Decisions
Building a Future-State Human Factors Strategy: Harnessing Historical PFS Data While Applying a Risk-Based Framework to Ensure Every New Drug-Device Combination Remains Safe, Effective, and Patient-Centric
Session Reserved for Sponsor
Patient-Centric Device Development: Designing Drug Delivery Solutions Around Real Patient Needs
Understanding patient needs and translating user insights into device and packaging design decisions
Improving usability, adherence, and accessibility through human-centred development approaches
Lessons learned from developing patient-friendly injectable devices and packaging solutions across diverse patient populations
Validating Patient Behaviour Insights to Improve Adherence Outcomes
Technical deep dive into the BEAMER behavioural model and segmentation of patient groups based on needs and adherence drivers
Results from EU and global pilot studies, including validation of adherence prediction and targeted support approaches
Designing patient-centric solutions to improve usability, outcomes, and value in healthcare systems
Session Reserved for Sponsor
Utilisation of Digital Endpoints in Injectable Drug Device Development
How digital endpoints and connected device data can generate objective insights into patient adherence, treatment outcomes, and device performance
Integrating digital endpoint strategies into device development programmes to support evidence generation and patient-centric product design
Chair’s Closing Remarks and Close of Day Two
Confirmed Speakers Include:
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