Tuesday, September 24
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?
Director, Global Quality Devices & Combination Product
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
anteris helvetia AG
General Manager & President of the Board
anteris helvetia AG
Connectivity – When, How and What?
15.00 – 18.00
While connected devices have sparked tremendous interests amongst drug and device developers, with huge potential benefits, there are a lot of challenges that the industry needs to overcome before being able to truly commercialize.
We will explore the following fast evolving topics to benchmark:
- 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
- Engineering considerations of your ‘smart’ injector
- Regulatory compliance, data privacy and ancillary services support
- The final question – does it make commercial sense?