Drug/Device Combination Products Design & Development Summit

March 2017



Hotel Riu Plaza Berlin

Martin-Luther-Straße 1, 10777

About Summit

Combination products are still relatively new delivery systems for health care professionals and patients. New techniques and methods are crucial for precision administration with minimal chance of incurring harm. Technical requirements are ramping up through new regulations and legalisms. It is an honour and privilege to invite you to discuss the key aspects of design control and latest practices in combination products development.

Who Should Attend

Chief Executives, Vice Presidents, Directors, Department Heads, Leaders, Managers specialising in:

  • Combination Products
  • Autoinjectors
  • Design Controls
  • Human Factors
  • Device Development
  • Device Manufacturing
  • Quality Assurance/Control
  • Compliance
  • Risk Management
  • CMC
  • Pre-filled Syringes
  • Parenteral Products
  • Device Design
  • Usability Engineering
  • Device Engineering
  • Drug Delivery
  • Product Quality
  • Regulatory Affairs
  • Research and Development
  • Packaging
Key Practical Learning Points of the Summit

Aligning regulations and processes
Key aspects of design control implementation
Risk assessment for faster product realisation
Insights into V&V methodology
Best practices in testing and evaluations
Human factor analysis
Technical challenges and correct specifications
Bijan Elahi

Medical Device Risk-Management Expert


Carsten Worsøe

Principal Scientist

Novo Nordisk A/S

Dr. Stephen A. Barat

Head of Pre-Clinical & Early Clinical Development


Florian Wildenhahn

Section Head, Human Factors Engineering

F. Hoffmann-La Roche

Jakob Lange

Account Director


Mike Wallenstein

Director QA / Team Lead Devices & Combination Products

Novartis International

Udo Stauder

Global Device Project Leader




Sponsors and Partners


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