Ron Brown, Risk Science Consortium, LLC - Qepler Summits And Conferences

Ron Brown

Owner and Principal Toxicologist
Risk Science Consortium, LLC
USA

Related Sessions:

2nd Annual Genotoxic Impurities in
Pharmaceuticals Summit 2021

Genotoxic Impurities in Pharmaceuticals strategies & new methodologies: analysis, in silico & regulations. Challenges & opportunities.
  • 15 Jul 2021
  • Virtual,
  • Pharma
Day 2: Friday, 16 July 2021
CASE STUDY: Handling mutagenic extractable and leachable compounds released from devices.

Genotoxic compounds can be released from some medical devices during their clinical use. The ISO 10993-17:2002 standard outlines steps to assess the risk posed by patient exposure to genotoxic compounds released from device materials. It is important to note; however, that the ISO 10993-17 standard is currently undergoing revision and the procedures for conducting a toxicological risk assessment of genotoxic compounds are likely to change following revision of the standard. This talk will outline the proposed changes to the ISO 10993-17 standard regarding methods to assess the risk posed by patient exposure to genotoxic compounds released from medical devices and will describe steps to mitigate the risk using risk management strategies. The talk will also briefly address how Carcinogenic, Mutagenic, and Reproductive (CMR) compounds will be handled in Europe under the new Medical Devices Regulation 2017/745/EU.

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