Event Information

Event Topic:
The Science of Medical Device Poisons – Updates to ISO 10993-17

Event Description:
Chemical characterization is conducted to ensure that poisonous compounds aren’t released by medical devices that would do more harm to the patient than good. In order for the data generated to be useful, it needs to be evaluated by an expert in toxicology. The details of toxicological risk assessment can make or break a medical device submission and the FDA has had special interpretation of the standard which supports tox assessment (ISO 10993-17) as well as their own requirements. The rules for toxicological risk assessment are changing, with far-reaching potential effects. One key question is regarding how exposure should be understood and calculated.

Date/Time:
Date(s) - 12/07/21
8:30 am - 10:30 am

Event Location:
Zoom talk: https://us02web.zoom.us/j/88274227563:

Speaker Information

Event Speaker:
Sarah Campbell

Event Speaker Title:
Principal Toxicologist

Event Speaker Company:
Nelson Labs

Event Speaker Bio:

Dr. Campbell is a Board Certified Diplomate of the American Board of Toxicology. She has over 20 years of experience working in toxicological research, 20 years of applied analytical chemistry experience, 14 years of experience in pharmaceutical research (including both clinical and nonclinical), and 12 years of experience as a bench chemist. Her particular areas of interest include medical device and pharmaceutical nonclinical program design and implementation, investigative toxicology, risk assessment of extractable & leachable compounds from medical devices, and regulatory interactions.

Event Details

Cost:
$0

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