Program

TRAINING DAY  October 4, at 9 am – 5 pm

Training day in connection to the conference, with the goal of learning more about different topics.
Come together and discuss topics with like-minded persons during breaks and group exercises.

9 am – 11.00 am (includes ½ hour coffee break) – Part 1, Limulus Bio – Monica and Lina

11 am – 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 include group discussions and exercises included.

Certificiates will be issued at the end of the training day. 

CONFERENCE DAY 1  October 5, at 9 am – 5 pm

Chairman for 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)

Ted Heise (US) – Current considerations for establishing a practical AET – including 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 to in vitro sensitization: obstacles, and potentials to achieve regulatory acceptance

Miki Giffin (Nelson Laboratories, US)  – In vitro thrombosis testing

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 and the program advisory committee and enjoy the entertainment during a nice three-course evening dinner. 

CONFERENCE DAY 2  October 6, at 8.30 am – 4 pm 

Chairman for 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 from a 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

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, including 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 – the use of TRA from a manufaturer perspective

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