Qepler | summits & conferences | Drug/Device Combination Products Summit, Berlin, 4 December 2018
Event Location:
Berlin, Germany
NH Collection Berlin Mitte am Checkpoint Charlie Leipziger Str. 106-111
04 December 2018 - 05 December 2018

Conference Overview

Drug-device combination products represent the next wave of drug delivery devices of increasing complexity. Their development requires a 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:

  • Integration of drug and device: combination product mindset
  • How to prioritize different regulations in product development
  • Risk-based approaches to design and development of drug delivery systems
  • Guidelines in design control for combination products
  • Turning user needs into design inputs
  • Human factors validation vs. design validation
  • Design verification strategies
  • Key quality systems expectations during design
  • Biocompatibility evaluation of combination products
  • Stability and shelf-life successful practices
  • Clinical and safety parameters for combination products
  • Technology transfer during lifecycle of combination products
  • Documentation requirements for combination products
  • Best practices for post-approval changes
  • Considerations on legacy products
  • Digitalisation to support combination product development

Meet our Speakers



Harshal Shah

Cambridge Consultants

chaired a panel discussion on the digitisation of clinical trials and next gen injectable devices, with speakers from Novartis, Roche, Janssen, Sanofi, SHL Group and Corvus Device.