FREE ONLINE WEBINAR: To continue supporting our customers' needs this webinar is dedicated to manufacturers only. To allow all interested companies attend, maximum two delegates form the same company will be admitted. Due to the type of event and limited audience capacity, participation of companies not included in this category will not be accepted. Attendance will be confirmed from the event's organizers.
DATE: March 11, 2021 | 3.00 PM - 4.00 PM CET
OFFICIAL LANGUAGE: English
ATTENDEES CAPACITY: This event has alredy reached maximum attendee capacity.
SUBMISSION LINK: https://attendee.gotowebinar.com/register/5503714717273140236
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Introduction and overview
ISO 10993-18:2020 “Biological evaluation of medical devices — Part 18: Chemical characterization of medical device materials within a risk management process” has significantly shaped the approach to the chemical characterisation of medical devices. Toxicological risk assessment should keep up with this new approach and be in line with the overall biological evaluation. In order to reflect this impact also ISO 10993-17 is under a substantial revision. We can immediately observe the deep level of this standard’s changes in the transition to “Toxicological risk assessment of medical device constituents” instead of “Establishment of allowable limits for leachable substances”.
The medical devices industry still has to wait before having this new document published but competent authorities and notified bodies are already placing an increasing emphasis on toxicological risk assessment with higher expectations compared to the current version in use. We aim to provide valuable insights and showcase the state-of-the-art for a toxicological risk assessment of a medical device. An up-to-date case study including the use of of in silico methods will be discussed to highlight relevant changes.
Topics
- Chemical characterisation of medical devices: ISO 10993-18:2020
- Toxicological risk assessment: ISO 10993-17
- New approaches in toxicological evaluation
- In silico methods
- Case study
- Q&A
Who should attend?
- Regulatory affairs & QA experts
- Research, design & manufacturing engineers
- Experts involved in the evaluation of Medical Devices
- Product Managers & Laboratory Managers
- Process development & system engineers
- Toxicologists & biological safety experts
Keynote speaker
Paolo Pescio, ERT
European Registered Toxicologist with a M.S. in Applied Toxicology and Biomedical Engineering has over 15 years of experience in biological evaluation of medical devices with a successful background as Study Director and Test Facility Manager. He is Consultany's Team Business Unit Manager within Eurofins Medical Devices Testing Italy and Senior Scientific Director in Eurofins Medical Device Testing Europe. He is also Healthcare Engineering HAS consultant for EU Commission and adjunct professor at the University of Milan and Fondazione Alma Mater of Bologna. Former member of ISO TC194 and CEN TC.
