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 7, 2024 | 3.00 PM - 4.00 PM CET
OFFICIAL LANGUAGE: English
SUBMISSION LINK: https://attendee.gotowebinar.com/register/7602990301774841946
ATTENDEES CAPACITY: 500 delegates
The event will be hosted within Go ToWebinar platform. Your registration request for this webinar will be submitted to the organizer for approval. You will receive information via email regarding your registration status.
Introduction
The webinar ''Strategic Implementation of ISO 10993-17:Disposable Medical Devices'' aims to give an overview of the new Part 17 of ISO 10993, discussing the main and new key concepts described in it and focusing on its applicability in relation to specific types of devices, such as disposable medical devices.
The revisions proposed in 10993-17 will expand toxicological risk estimation to include prioritization of chemicals by screening limit, estimation of exposure dose for each component, and use of risk acceptance criteria to assess the margin of safety.
Some of these new concepts will be analyzed in order to determine when and how they can be applied to specific cases with the goal of defining increasingly tailored strategies for different medical devices.
Speakers
Paolo Pescio is a European Registered Toxicologist with a MSc in Applied Toxicology and Biomedical Engineering, Paolo has over 15 years of experience in biological evaluation of medical devices and toxicological risk assessment for pharmaceutical products. He is Senior Scientific Director at Eurofins Medical Device Testing Europe, member of ISO TC 194 and CEN TC 206 and adjunct professor at the University of Milan and Fondazione Alma Mater of Bologna. He is a former Healthcare Engineering HAS consultant for EU Commission.
Raina Sota is In Eurofins group since 2018 as Technical support for project management of biocompatibility analysis, GLP In Vivo and In Vitro studies and routine analysis of Medical Devices. From 2020, Toxicologist and Consultant in the Medical Devices sector, as part of Medical Devices Consulting Team, dealing with Toxicological Risk Assessment after Extractable & Leachable studies performed on Medical Devices (ISO 10993-17:2023 - Biological evaluation of medical devices_Part 17: Toxicological risk assessment of medical device constituents and ISO 10993-18:2020 - Biological evaluation on of medical devices — Part 18: Chemical characterization on of medical device materials within a risk management process). She is also Team Coordinator of the Medical Devices Toxicology group in Eurofins Regulatory & Consultancy Services Italy Srl;
