Purpose and use
The course provides participants with a comprehensive understanding of Toxicological Risk Assessment (TRA) for medical devices, with a particular emphasis on the new ISO 10993-17:2023. TRA is a critical aspect of ensuring the safety and biocompatibility of medical devices. The course aims to give participants the knowledge and skills necessary to conduct effective TRA in compliance with international standards and regulations.
 
Day 1 focuses on TRA in general, covering fundamental concepts and methodologies. It guides participants through the entire TRA process, from planning according to ISO 10993-1, chemical characterization per ISO 10993-18, and overall biological safety assessment. The day also addresses the practical implementation of TRA using real cases and provides insights into dealing with situations when toxicological data is scarce.
 
Day 2 narrows the focus to the new TRA concepts and terms introduced in the ISO 10993-17:2023. This includes the exploration of new definitions, clauses, and flowcharts. Special attention will be given to topics such as Total Quantity (TQ), Margin of Safety (MOS), Estimated Exposure Dose (EEDmax), release kinetics and Point Of Departure (POD). The day also dives into the application of toxicological screening limits (TSL) and the journey, using actual case studies, from chemical characterization, through extractable and leachable studies, to a comprehensive TRA.
 
Content
Day 1:

• Introduction to Toxicological Risk Assessment (TRA) and its significance in medical device safety
• ISO 10993-1 strategy for biological evaluation
• Identifying the need for TRA based on ISO 10993-18
• E&L studies: Design and Role
• The TRA paradigm and process, including hazard identification, dose-response evaluation, exposure assessment, and risk characterization
• Workshop on sourcing relevant toxicological data
• Strategies when data is lacking: grouping, read-across, and in silico approaches

Day 2:

• New terms and parts in ISO 10993-17:2023
• Analysis of new definitions, clauses, and flowcharts
• Understanding and calculating Total Quantity (TQ)
• Margin of Safety (MOS): definition and assessment and use of terms such as EEDmax
• Toxicological Screening Limits (TSL)
• Integration of chemical characterization, extractable studies, and leachable studies into the TRA process
• Hands-on experience on the new concepts and how a “new” TRA looks like according to ISO 10993-17:2023

It is possible to register for both days or just for one day.
 
Target group
The course is designed for professionals working within the medical device industry, particularly those involved in ensuring the safety and biocompatibility of medical devices. The target audience includes:
 

• Regulatory and Quality Assurance professionals
• Toxicologists and Risk Assessment experts
• Biocompatibility and Materials specialists
• Professionals involved in chemical characterization

This course caters to individuals who need a comprehensive understanding of TRA methodologies, both in general and in relation to the latest updates in the ISO 10993-17:2023.
 
Trainer
Paolo Pescio, Managing Director, Eurofins Regulatory & Consultancy Services Italy