8:00
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Arrival and Check-In (Coffee and Tea available)
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9:00
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Welcome to the Veranex training day!
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9:10 - 13:00
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Training by Veranex Biocompatibility and Toxicology team (Coffee Break included, approx. 11:00-11:30)
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9:10 - 10:00
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Understand the new concepts of the 2024 version of the ISO 18562 standard series
- What do you need to think of at biocompatibility evaluation of breathing gas pathway devices?
- What are the potential hazards
- Evaluation process
- Focus on main updates in the 2024 versions and their impact
- Q&A
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10:00 - 12:00
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Understand the new concepts of ISO 10993-17: 2023
- Explanation of changes in the standard with focus on the new concepts
- Group exercise based on case studies including discussions
- Focus on tricky cases, such as:
- Children / neonates
- Carcinogenic substances
- Q&A
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12:00 - 13:00
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New Approach Methodologies (NAMs), when can we use these tools and what are the hurdles for regulatory acceptance
- Emerging NAMs with focus on in vitro methods
- Current global regulatory acceptance for NAMs
- Case studies
- Q&A
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13:00 - 14:00
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Lunch
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14:00 - 17:00
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Training by Nelson LABs (Coffee Break included, approx. 15:15-15:45)
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14:00 - 14:15
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Introduction to reusable devices and reprocessing
- Single-use versus reusable devices and why they require different approaches
- High-level overview of reprocessing for reusable medical devices and validation requirements
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14:15 - 15:15
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Cytotoxicity testing
- One test for many applications: How to design cytotoxicity test depending on what you want to evaluate and how to interpret results?
- As a biocompatibility endpoint
- As part of a reprocessing validation
- As part of an End-of-Life cycle evaluation
- How to handle failures
- Is there a real risk to the patient versus the sensitivity of the assay?
- Case study
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15:45 - 17:00
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End-of-Life cycle evaluation
- How to approach End-of-Life cycle evaluations? What should be evaluated?
- General strategy & endpoints to evaluate (biocompatibility, soil build-up, functionality, …)
- Single-use versus reusable medical devices
- EU versus US (MDR versus FDA)
- Case study
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Networking event at Hey IDA
Directly after the training, all conference and training day participants are invited to our networking event at Hey IDA, by the canals at Kalvebod Brygge in Copenhagen. We look forward to welcoming you to this event and hope you will take advantage of this opportunity to connect with other attendees, speakers and sponsors.