Program

The Program

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Training Day in Partnership with Nelson Labs - October 15th

9:00 AM

Welcome to the Veranex training day!

9:10 AM - 1:00 PM

Training by Veranex Biocompatibility and Toxicology team (1/2 hour Coffee Break included)

9:10 AM - 10:00 AM
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

10:00 AM - 12:00 PM
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

12:00 PM - 1:00 PM
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

1:00 PM - 2:00 PM

Lunch

2:00 PM - 5:00 PM

Training by Nelson LABs (1/2 hour Coffee Break included)

2:00 PM - 2:15 PM
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

2:15 PM - 3:15 PM
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

3:15 PM - 3:45 PM
Coffee Break

3:45 PM - 5:00 PM
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

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.

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Conference Day 1 – October 16th

8:00 AM | Arrival and Check-In

Welcome from hosts Veranex

Emerging Trends – Biocompatiblity Insights from Copenhagen ‘22, Annapolis ‘23 and Copenhagen ’24
Ron Brown (Risk Science Consortium, US)

Knowing Me, Knowing You: Toxicity Data Quality

Demystifying REACH: Overview of Database and Data Quality,Read Across as Example
Erwin Annys (ECHA, Finland)
Deriving Tolerable Intake (TI) from REACH, Including Read Across
Chris Waine (Bibra toxicology advice & consulting, UK)
Q&A Session

No Doubt About It: Evidence and Uncertainty in Chemical Characterization

Support for Simulated Use Extraction and Impact of Degradation
Ted Heise (Convenor 10993-18, MED Institute, US)
The Value of FDA’s CLAP List in Developing and Optimizing Chemical Characterization Studies
Piet Christiaens (NelsonLabs, BE)
Q&A Session

When All is Said and Done: Clinical Relevance of Biocompatibility Tests

Clinical Risk in the Real World — Experience from 20000 Implantable Devices
Lars Magnus Bjursten (Convenor ISO 18562, Senior Professor of Bioimplant Research, SE)
Medical Devices: Adverse Events, the Skin and Real-World Data
Cecilia Svedman and Martin Mowitz (Skåne University Hospital Malmö, SE)
Clinical Relevance of Extractions in Biological Tests
Bob Przygoda (Adventure Biocompatibility Consulting, US)

The Name of the Game: Science and Evidence in Biocompatibility

KEYNOTE: Evidence-Based Toxicology for Safety Assessment of Medical Devices, MMP as an Example
To Be Confirmed
Expert Panel: So the Results Are In — What Does it All Mean?
5:00 PM | Hasta Mañana: Day 1 Closing Summary
7:00 PM | Conference Dinner at IDA Conference Center (Dinner ticket required)

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Conference Day 2 – October 17th

08:30 AM | The Visitors: Leveraging Approaches from Other Fields of Regulatory Toxicology

Introduction – Day 2
Philip Clay (Chorley Consulting, UK)
KEYNOTE: Using NAMs to Improve Clinical Relevance of Biological Tests
To Be Confirmed
Expert Panel: Learning from Others — What is the State of the Art?

I do, I do, I do, I do, I do: Current Challenges and Regulatory Acceptance

Biocompatibility Hot Topics — A New ISO 10993-17; Legacy Devices and Low Risk Devices Under MDR
Katarina Weidmann (TÜV SÜD, Germany)
US Regulatory Application of ISO 10993
To Be Confirmed
The New Part 17 — New Approaches and Future Expectations
Sherry Parker (SParker Consulting, US)
Applying Part 17 to a Range of Data Sets: Real World Experience
Rona Middlemiss (Chorley Consulting, UK)
Q&A Session

I Have a Dream: Closing Plenary — Where to from Here?

Conference Summary and Learnings
ISO TC 194 Paris (21-25 Oct) Preview Including Progress on the New Part 1
A 5-Year Plan — Biocompatibility 2029
In Conversation: Jeremy Tinkler (Chair ISO TC 194, ICON, UK) and Arthur Brandwood (Project Leader – revision of ISO 10993-1, AU)
4:00 PM | Thank You for the Music: Closing Remarks (Veranex)

*Please note that the program is subject to change

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