The 12th Pre-Filled Syringes, Wearable & Autoinjector Drug Delivery Summit brings together global leaders across pharma, medtech, device engineering, regulatory affairs, and digital health to explore the technologies and strategies redefining injectable therapy delivery.

From connected devices and large-volume biologics to regulatory navigation and sustainable material innovation, this year’s agenda reflects the rapid evolution of combination products and drug delivery platforms.

Below is a preview of the expert insights shaping this year’s discussions.

DAY ONE

Device Evolution & Regulatory–Compliance Interplay

Day One focuses on the intersection of device innovation, manufacturing realities, and evolving regulatory expectations.

Alex Fong — Owen Mumford Ltd

Alex will share strategic insights into supply chain resilience, raw material transformation, and the commercial realities behind sustainability initiatives.

Why this matters now:
With geopolitical instability, oil dependency concerns, and bio-material innovation accelerating, device manufacturers must rethink sourcing, cost structures, and long-term material viability. Sustainability is no longer just environmental — it’s operational and financial.

Claus Geiger — Gameta Pharma Consulting

Claus will explore how patient-centric design principles are being embedded into drug-device combination development, from requirements definition to human factors integration.

Why this matters now:
As self-administration rises and therapies move into the home, usability and adherence directly impact regulatory approvals, outcomes, and market adoption.

Abha Raveau-Violette — CPMD Consulting Ltd.

Abha will address global regulatory pathways for combination products and how to align cross-market approval strategies.

Why this matters now:
Regulatory frameworks continue to diverge globally, making early alignment essential to avoid delays and duplication in submissions.

Carolien Buvé — Nelson Labs Europe

Carolien will examine extractables and leachables considerations, material selection risks, and safety testing frameworks for pre-filled syringes.

Why this matters now:
Biologic sensitivity and long shelf-life expectations are placing increased scrutiny on container closure systems and material compatibility.

Ortzi Olasolo — Beyond Conception GmbH

Ortzi will focus on navigating notified body opinions, dossier preparation, and post-approval change management.

Why this matters now:
Under MDR, notified body capacity and expectations remain major bottlenecks, making proactive regulatory strategy essential.

Gea Bianchi — Flex

Gea will explore cybersecurity compliance and software integration in connected drug delivery devices.

Why this matters now:
Smart injectors and digital therapeutics generate patient data, requiring robust cybersecurity frameworks aligned with evolving regulations.

Phil Estepa — Ionis Pharmaceuticals, Inc.

Phil will discuss scalable development models and platformed manufacturing approaches for drug delivery systems.

Why this matters now:
Speed to clinic and commercialization is critical as biologic pipelines expand and competition intensifies.

Mehul Desai — Enable Injections, Inc.

Mehul will highlight wearable and on-body injector technologies for large-volume drug delivery.

Why this matters now:
High-viscosity biologics and oncology therapies are pushing the limits of traditional injection formats, driving wearable adoption.

Deep S. Bhattacharya — Pfizer Inc.

Deep will present advances in subcutaneous delivery systems and evaluation tools for high-dose biologics.

Why this matters now:
The industry is shifting IV therapies to subcutaneous formats to reduce healthcare burden and improve patient convenience.

René Holm — University of Southern Denmark

René will explore formulation strategies behind long-acting injectables.

Why this matters now:
Extended-release therapies improve adherence, reduce dosing frequency, and enhance treatment outcomes.

Philipp Richard — Ypsomed Delivery Systems

Philipp will discuss connected delivery platforms and their application in clinical trials.

Why this matters now:
Device connectivity enables real-time adherence tracking and data capture, transforming trial design and patient monitoring.

DAY TWO

Sustainability, Technology, Patient Focus & The Future

Day Two shifts toward future-facing innovation, sustainability execution, and advanced engineering tools.

Asmita Khanolkar — SMC Ltd

Asmita will address end-to-end development considerations for combination products.

Why this matters now:
Integrated device strategies are essential as advanced therapies and complex biologics enter clinical pipelines.

Bjarne Sørensen — Phillips-Medisize

Bjarne will explore electromechanical device platforms, reusable systems, and packaging flexibility.

Why this matters now:
Reusable and adaptable platforms support sustainability goals while expanding therapeutic applications.

Diana Koschel — BD

Diana will focus on analytical methods used to predict drug-container interactions.

Why this matters now:
Advanced analytics and AI-supported characterization improve stability forecasting and reduce development risk.

Stefano Pilati — Stevanato Group

Stefano will share long-term stability findings for prefilled syringe systems.

Why this matters now:
Container performance directly impacts biologic integrity and regulatory acceptance.

Frauke Schuurkamp — Emergo by UL

Frauke will examine human factors risks and usability pitfalls in device development.

Why this matters now:
Regulators increasingly require validated usability data to ensure patient safety.

Christian Proff — Hoffmann-La Roche Ltd

Christian will discuss device and packaging performance under ultra-low temperature conditions.

Why this matters now:
Cell and gene therapies demand extreme cold-chain resilience.

Glenn Svedberg — Nolato

Glenn will demonstrate virtual simulation and tolerance modeling in device manufacturing.

Why this matters now:
Digital engineering reduces prototyping cycles and accelerates time-to-market.

Cedric Gysel — Be Circular

Cedric will present circular economy models and medical device recycling strategies.

Why this matters now:
Scope 3 emissions and healthcare waste are driving industry-wide sustainability transformation.

Join the Leaders Driving Drug Delivery Forward

The #Epfs summit 2026 offers a unique platform to exchange insights, benchmark strategies, and explore partnerships shaping the next generation of injectable therapies.

From regulatory foresight and digital health integration to wearable innovation and sustainable design, the agenda reflects the technologies redefining drug delivery.

12th Pre-Filled Syringes Summit is taking place on 11-12 March in Munich, Germany
 Secure your place and be part of the conversation shaping the future of injectable drug delivery.

As the conversation continues to evolve, we are excited to carry these discussions forward at the

8th Drug-Device Combination Products Summit  in Amsterdam I September 2026, where industry leaders will once again come together to exchange expertise. The event will spotlight cutting-edge innovations, with solution providers presenting technologies and services designed to address today’s most pressing drug-device challenges.