Why should you attend?

Combination Product Development & Lifecycle Strategy – Navigate integrated drug–device development from early platform and supplier selection through design controls, risk management, regulatory submission, industrialization, and lifecycle management.

Pre-filled Syringes, Cartridges & Primary Container Systems – Address container selection, material compatibility, break-loose and glide forces, stopper performance, silicone-related considerations, extractables & leachables, and container closure integrity.

Autoinjectors, Wearable & On-Body Delivery Systems – Explore the development and scale-up of next-generation autoinjectors, patch and wearable injectors, and on-body systems for increasingly complex subcutaneous therapies.

Large-Volume, High-Viscosity & High-Dose Drug Delivery – Examine the device, formulation, container, needle, and usability challenges associated with concentrated biologics, high-dose therapies, and the shift from IV to subcutaneous administration.

Biologics, Long-Acting Injectables & Emerging Therapies – Explore delivery strategies for biologics and other challenging formulations, including long-acting products and therapies requiring new approaches to device and primary-container design.

Device Engineering, Verification & Performance – Advance robust injection-system development through design controls, modelling, performance characterization, functional testing, reliability engineering, design verification, and scalable platform approaches.

Human Factors, Usability & Patient-Centric Design – Integrate real-world patient needs, use-related risk, formative and summative studies, adherence, accessibility, and human factors engineering throughout combination-product development.

Regulatory Strategy, Quality & Risk Management – Navigate evolving EU, US, and global expectations for drug–device combination products, including Article 117, design controls, post-market considerations, quality systems, and risk-management strategies.

Manufacturing, Assembly & Industrialization of Injection Devices – Address design transfer, automation, component and supplier control, assembly, fill-finish interfaces, inspection, manufacturing scalability, and reliable commercial supply.

Connected Devices, Digital Health & Sustainable Design – Assess where connectivity, digital ecosystems, AI and data can add meaningful value to injection devices while addressing material selection, lifecycle impact, circularity, and evolving sustainability requirements.