Program

The Program

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Training Day in Partnership with Nelson Labs - October 15th

8:00	Arrival and Check-In (Coffee and Tea available)
9:00	Welcome to the Veranex training day!
9:10 - 13:00	Training by Veranex Biocompatibility and Toxicology team (Coffee Break included, approx. 11:00-11:30)
9:10 - 10:00	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 - 12:00	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 - 13:00	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
13:00 - 14:00	Lunch
14:00 - 17:00	Training by Nelson LABs (Coffee Break included, approx. 15:15-15:45)
14:00 - 14:15	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
14:15 - 15:15	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
15:45 - 17:00	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 | Arrival and Check-In (Coffee and Tea available)

9:00 | 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
Erwin Annys (ECHA, Finland)

Deriving Tolerable Intake (TI) from REACH, Including Read Across
Chris Waine (Bibra toxicology advice & consulting, UK)

Q&A Session

10:45 - 11:15 | Coffee Break

No Doubt About It: Evidence and Uncertainty in Chemical Characterization

Considerations on Simulated Use Extraction, Device Degradation, and CDRH Chemical Analysis Guidance
Ted Heise (Convenor 10993-18, MED Institute, US)

How the CLAP-List May Be Used to Address Some Recent FDA Recommendations (Draft FDA Guidance; 2024) in Developing and Optimizing Chemical Characterization Studies
Piet Christiaens (NelsonLabs, BE)

Q&A Session

12:30 - 13:50 | Lunch

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)

15:20 - 15:50 | Coffee Break

The Name of the Game: Science and Evidence in Biocompatibility

KEYNOTE: Evidence-Based Toxicology for Safety Assessment of Medical Devices, MMP as an Example
Thomas Hartung (Johns Hopkins Bloomberg School of Public Health, US)

Expert Panel: So the Results Are In — What Does it All Mean?

17:00 | Hasta Mañana: Day 1 Closing Summary

19:00 | Conference Dinner at IDA Conference Center (Dinner ticket required)

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Conference Day 2 – October 17th

08:30 | 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
Helena Kandarova, (Institute of Experimental Pharmacology and Toxicology, CEM, Slovak Academy of Sciences, Slovakia)

09:25 - 09:50 | Coffee Break

Yes, You Can Replace the Animal Studies: Cross-Sector Opportunities for Medical Device Safety Assessment
Jeffrey Brown (PETA, Germany)

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

Hydrogels, Dressings, and Soft Polymers: Testing and Evaluating Devices Not Compatible with 10993-12
Beau Rollins (Convatec, US)

Q&A, including follow up from the Veranex Biocompatibility Coffee Break on September 26

11:30 - 13:00 | Lunch

ISO 10993-17, US FDA Expectations for TRAs, and Potential Impact of Draft Chemical Characterization Guidance
Sherry Parker (SParker Consulting, US)

Applying Part 17 to a Range of Data Sets: Real World Experience
Rona Middlemiss (Chorley Consulting, UK)

Biocompatibility Hot Topics – A New ISO 10993-17 and Legacy Devices under MDR
Katarina Weidmann (TÜV SÜD, Germany)

Q&A Session

14:45 - 15:15 | Coffee Break

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)

15:55 | Thank You for the Music: Closing Remarks (Veranex)

*Please note that the program is subject to change

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