LIVE WEBINAR: Blood is not just blood - Why a Predicate Sample is recommended in Hemocompatibility Testing
Reister now for the free live webinar "Blood is not just blood - Why a Predicate Sample is recommended in Hemocompatibility Testing"
Watch the webinar on-demand
About the webinar
The ISO guideline 10993-4 describes the test design and parameters required for the hemocompatibility analysis of medical devices in direct or indirect contact with blood. Several tests can be performed to assess the interactions of medical devices with blood.
However, the ISO-guideline does not specify strict exclusion criteria for the evaluation of a clearly positive or negative effect of the device. Therefore, an effect induced by the medical device cannot always be excluded on the basis of the negative control alone or, if applicable, in comparison with the historical data. Especially the results of ELISA tests cannot be conclusively assessed as clearly negative. Therefore, the parallel testing of a predicate device can be crucial to exclude a relevant biological effect of the test device.
The webinar will cover the following key points in general:
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What is a predicate device and how should it look like
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Which tests can benefit from a predicate device
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Example of data interpretation and discussion of a real case
At the end of the webinar there is going to be a live Q&A Session.
This webinar is presented by Dr. Christine Freitag, Deputy Head of the Department in vitro Pharmacology and Toxicology and Group Leader for Hemocompatibility Testing at Eurofins Medical Device Testing in Munich
OneSession is offered for this event:
Session in ENGLISH, 20.06.23., 11:00-12:00 (CET)
Speaker:
Dr. Christine Freitag is group leader of hemocompatibility testing in the Department in vitro Pharmacology and Toxicology at Eurofins Medical Device Testing in Munich. She has been working in toxicology for 12 years and holds a PhD from the Institute of Food Chemistry and Toxicology at the University of Vienna. In 2016, Christine Freitag started as a study director for genetic toxicology at Eurofins Munich and became deputy head of the Department of in vitro Pharmacology & Toxicology at the end of 2018, which includes genetic toxicology, alternative methods, cytotoxicity and hemocompatibility testing. The Department of in vitro Pharmacology & Toxicology has many years of experience in testing medical devices in addition to in-depth knowledge of chemicals and pharmaceuticals.
