Programme

Countdown to first conference day

Day(s)

:

Hour(s)

:

Minute(s)

:

Second(s)

TRAINING DAY  May 3, at 9 am – 5 pm

Training day in connection to the conference, with the goal to learn more about different topics.
Get together and discuss with like-minded during breaks and group exercises!

9 am – 11.30 am (includes ½ hour coffee break) – Part 1, Limulus Bio – Monica and Lina

1 pm – 2.30 pm (includes 1 hour lunch break) – Part 18, tbd. 

2.30 pm – 5 pm (includes ½ hour coffee break) – Part 17, tbd.

Each session will have group discussions and exercises included.

Diplomas will be received at the end of the training day. 

CONFERENCE DAY 1  May 4, at 9 am – 5 pm

Chairman of the day: Arthur Brandwood & Sherry Parker

Welcome to our world – the current state of ISO 10993


Keynote speaker: Jeremy Tinkler (UK) – Introduction – the ISO 10993 family – and links to regulation

Michelle Kelly (UK) What works and what does not – ISO 10993 as a regulatory tool

Understanding the device: Chemical Characterization (ISO 10993-18)


Julian Kirch (DE) – Short introduction about chemical characterization and assessing from a paper-based standpoint. What is the minimal that may be needed?

Ted Heise (US) – Current considerations for establishing a practical AET – incl. solvent exchange, concentration, and pooling

Piet Christiaens, (BE) – Best analytical practices for minimizing “unknown” compounds

Questions and answers on the use of chemical characterization 

New science,  new approaches in biological evaluation

Ron Brown (US) – How to work with regulators to do things differently

Rose-Marie Jenvert (SE) – Updates in vitro sensitization: obstacles, and potentials to get regulatory acceptance

Mikaelle Giffin (US) – In vitro thrombosis

Christian Pellevoisin (FR) – Taking new science into standards – case study of in vitro irritation

Panel Discussion – Building a new paradigm

CONFERENCE DINNER 

Time tbd. 

Take the opportunity to connect with other conference participants, the program advisory committee and enjoy entertainment during a nice three-course dinner together in the evening. 

CONFERENCE DAY 2  May 5, at 8.30 am – 4 pm 

Chairman of the day: Arthur Brandwood & Sherry Parker

Special Cases – Going beyond the Table A1

Paul Dixon – Evaluation of devices in indirect contact via the airways according to ISO 18562, updates within the standard series and manufacturer perspective

Genotoxicity and carcinogenicity – Calibrating the risks?

Todd Kennedy (US) – Setting the Analytical Evaluation Threshold.  How sensitive does chemical characterization of medical devices need to be? Calibration of analytical evaluation thresholds with the carcinogenic potency database (Is 120 ug/day protective for short and long-term devices; also applied to TSL approach)

Toxicological Risk Assessments – Part 17 gaining attraction

Sherry Parker (US) – ISO 10993-17: Updates and Application of New Concepts in Toxicological Risk Assessments of Medical Devices – incl TSL

Hedwig M Braakhuis (NL) – Toxicological risk assessments in reproductive and developmental toxicity; New SCHEER Guidance on the benefit-risk assessment of the presence of phthalates in certain medical devices, incl MDR perspective of CMR substances

Joel Cohen (US) – Use of Read-Across in TRA of Medical Devices (Tools and best practices)

Philip Clay (UK) – Case studies – manufacturer perspective of the use of TRA

Closing plenary

Arthur Brandwood (AU) – The future is a risky place

Panel Discussion – Risks, Returns and Regulation

 * The programme is in draft form and Limulus Bio reserves the right to make adjustments