Qepler | summits & conferences | 2nd Annual Drug/Device Combination Products Summit, 4-5 December 2019
Event Location:
Prague, Czech Republic
Novotel Praha Wenceslas Square Hotel Katerinska 1476/38
04 December 2019 - 05 December 2019

Conference Overview

Drug/device combination products represent the next wave of drug delivery devices of increasing complexity. Their development requires the number of technical challenges to consider - integrating drug and device systems, defining the elements of design control, determining quality systems and manufacturing processes. It is also critical to establish a regulatory and clinical strategy from early on in development. Our meeting facilitates a better understanding of both regulatory and practical aspects of developing drug-device combinations, as well as the management of combination products across the total product life cycle.

The featured talks on:

  • Preparing for EU MDR implementation and its implications on combination products.
  • Registering DDC products across the globe. LCM strategies and regulatory considerations.
  • Platform selecting and engaging the right stakeholders in the product development process.
  • Addressing the differences and gaps between drug and device development plans.
  • Streamlining a quality management system to support sustainable LCM.
  • Identifying essential performance requirements and associated control strategies.
  • Integration of design control throughout LCM. Design verification and process validation.
  • Risk-based approaches to design and development of drug delivery systems.
  • Utilizing human factors in combination products risk management.
  • How to compile a clinical evaluation for combination products.
  • Drug/device compatibility, safety evaluation and testing for combination products.
  • Best practices for post approval changes. Understanding when a change is a change.
  • Assessing post market surveillance to support effective lifecycle management.
  • Driving innovations to extend your combination product lifespan.
  • Connected digital technologies and next generation combination products.

Meet our Speakers

Our Sponsors

Speaker Sponsor
Intertek (Schweiz) AG



▸AbbVie ▸Ablynx ▸anteris medical ▸AOP Orphan Pharmaceuticals ▸Astellas Pharma ▸AstraZeneca ▸BIOCORP ▸Biogen ▸Boehringer Ingelheim microParts ▸Bristol-Myers Squibb ▸BSI Group ▸Corvus Device ▸Cytel ▸Design Science ▸Eli Lilly ▸Freelancer ▸GSK ▸H&B Electronic ▸H&T Presspart ▸Hanway Associates ▸Janssen ▸LEO Pharma ▸Maetrics ▸Medac ▸Medtronic ▸Nelson Labs ▸Nelson Labs Europe ▸Novartis ▸Orion Corporation - Orion Pharma ▸Pall Life Sciences ▸Pharmathen ▸Progress-PME ▸Regeneron Pharmaceuticals ▸Sanofi R&D ▸Sanofi-Aventis ▸sfm medical devices ▸Sharp Clinical Services ▸Spiegelberg ▸TERUMO EUROPE ▸tesa Labtec ▸Teva ▸UPM Raflatac


Serge Mathonet

Sanofi R&D

chaired a panel discussion with speakers from TERUMO EUROPE, Novartis, anteris medical GmbH, GlaxoSmithKline, AstraZeneca and Corvus Device.