Qepler | summits & conferences | Drug/Device Combination Products Summit, Berlin, 15 November 2018
Event Location:
Berlin, Germany
To be announced
04 December 2018 - 05 December 2018

The call for speakers is open now.
Please find below the tentative schedule. Speaking sessions will be grouped according to similar themes into blocks and published upon finalizing the agenda, so please check back!

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.