All summit sessions will be presented in English. While translation services are not provided, we welcome attendees from around the world and encourage everyone to join the discussions and networking opportunities.
9th Drug-Device Combination Products
Delivering Next-Generation Combined Drug-Device Products: Regulatory Reform, High-Volume Biologics, Sustainable Design and AI-Enabled Connectivity
Drug-Device Combination Products in 2027: New Rules, New Modalities, New Expectations
Combination products are now the standard way many of the world's most important therapies reach patients. From autoinjectors and pens to on-body injectors and connected inhalers, the device has become part of the therapy itself.
2027 is a year of change. Europe is implementing its new pharmaceutical legislation and revising the MDR and IVDR, FDA's ISO 13485-aligned Quality Management System Regulation is in force, and new requirements on PFAS, packaging waste and artificial intelligence are reaching product development teams.
Against this backdrop, the 9th Drug-Device Combination Products Summit, taking place 29–30 September 2027, gives development, regulatory, quality and supply teams the practical answers they need.
What Is Driving the Combination Product Market Now
Speakers
Event Preview
Key points
New EU Rulebook – Prepare for the new EU pharmaceutical legislation and the MDR/IVDR revision, including Notified Body Opinions and platform technologies.
Global Alignment – Build integrated EU–US technical files under FDA's QMSR and manage post-approval device changes across regions.
Large-Volume Biologics – Select the right primary container and device for high-concentration and large-volume subcutaneous delivery.
Materials & PFAS – Strengthen E&L, biocompatibility and material substitution strategies ahead of the EU PFAS restriction.
Human Factors – Use HFE – including comparative-use studies for generics and biosimilars – to accelerate approvals.
AI, Connectivity & Sustainability – Apply AI and connected data across the lifecycle and design for PPWR, reuse and lower environmental impact.
Who should attend
Chief Executives, Vice Presidents, Directors, Heads, Leaders, and Managers specializing in:
- Product Development & Design
- Manufacturing, Processing & Supply Chain
- Formulation & Pharmaceutical Products
- Packaging & Sustainability
- Quality, Compliance & Regulatory
- Digital Health & Connectivity
- Innovation & R&D
9th Drug-Device Combination Products
Delivering Next-Generation Combined Drug-Device Products: Regulatory Reform, High-Volume Biologics, Sustainable Design and AI-Enabled Connectivity
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FAQ
Your questions answered here.
Our events are designed to spark genuine connections. In-person participants benefit from structured formats like speed networking sessions, as well as informal interactions during the exhibition, coffee breaks, lunches, and networking dinners — where all participants are invited.
Virtual and hybrid attendees can also connect through our event platform, which supports chat, meeting requests, and live Q&A with speakers and peers.
You can register online via each event’s dedicated page. Once submitted, you’ll receive a confirmation and invoice by email. For special requests, feel free to contact our team directly to hello@etapahub.com or the contact person noted at the designated event page.
Yes — all registered participants receive access to post-event materials, including authorized speaker presentations (subject to permission), and other relevant documents.
If you’re unable to attend in person, a documentation package can be purchased separately. For selected hybrid events, we also offer a recording package with on-demand access to sessions.
We’d love to help you make the most of the summit! You can request the summit brochure or contact our team directly using the details below. Our team is happy to answer any questions and guide you in planning your participation.
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