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September 24-26
San Diego, USA

Be part of the device engineering evolution: 
From PFS to smart injectors to delivering
quality patient care

AgendaPre-Conference Workshops

Pre-Conference Workshops
Tuesday, September 24

Workshop A

The Buzzword – QMRS: From Regulatory to CMC to Product Management
08.00 – 11.00

A well thought-through and robust quality risk management device program is necessary to uphold product integrity and patient care. It should be embedded throughout the device team and product life cycle. This session will involve practical case studies and discussions to help you not only avoid pitfalls, but deliver excellent care for your patients and remain compliant.

This session will give you actionable takeaways on:

  • What a good QMRS looks like
  • Risk management and approaches to handling change throughout lifecycle
  • When you should act on your feedback and complaints
  • CAPA: it’s important to understand the root cause to avoid mistakes
  • How can it help you to extend your product lifespan?

Workshop Leader:

Merck - Leo V

Leonel Vanega

Former Director, Global Quality Devices & Combination Products, Merck, Principal, ResMedica Consulting


Workshop B

Excellent Device R&D to Ensure Longevity of Your Injector
11.30 – 14.30

A successful and patient centric injectorbegins at the product R&D stage, andincremental changes to your product design can offer significant impacts on usability and commerciality of your injector.

This session will offer you a step-by-step guide on:

  • The need to perform competitive analysis before commencing your R&D efforts</span
  • Agile approach, how to make your device development more efficient
  • Involving your users from the beginning into your R&D concept
  • Is your device connected? How to digitalize your device cleverly
  • Case studies of successful injectors life cycle and evolution's

Workshop Leaders:

anteris - J Thierry

Thierry Jomini
General Manager

anteris helvetia AG

anteris - Dirk K

Dirk Kreder
General Manager & President of the Board

anteris helvetia AG

Workshop C

Connectivity – To Connect or Not Connect…That is the Question?
15.00 – 18.00

Connected Devices have caught the attention of drug and device developers given the potential benefits, however, it is less clear how these companies leverage this advanced technology to their favor, where to begin with implementation and ultimately, how to commercialize.

In this session we will use various scenario case studies and discussion to:

  • Assess the quality, life cycle, and regulatory impacts of digital health across your organization
  • The importance of user and human factors testing for connected devices early on
  • Creation of an integrated device solution and platform implementation
  • The misconceptions and mistakes drug and devices companies are making with connected devices
  • Thoughtful Engineering considerations of your ‘smart’ injector
  • Regulatory compliance, data privacy and ancillary services support
  • The final question – to connect or not connect…does it make commercial sense

Workshop Leader:

Sutton Creek - Steven Badelt

Steven Badelt
Founder & Managing Partner

Suttons Creek, Inc.