Extractables and Leachables: Trends and Future Directions Part II
May 25, 2022 @ 11:00 am – 12:00 pm
The characterization of extractables and leachables is important for ensuring product safety for both drugs and medical devices. In the last few years, the issuance of the ISO 10993–18:2020 medical device guidance and several high–profile publications and round robin studies have resulted in the FDA increasing scrutiny of E&L analyses. Of particular interest is a review paper published very recently by scientists in the device center of FDA. These sources highlight important gaps in the way E&L studies are typically conducted. The complexity of these changes has been increased by the fact that the best practices and regulatory requirements for drugs and medical devices are different but not always appreciated. This roundtable discussion will provide an open forum for discussing these changes and for exploring current best practices. The panelists will also discuss the regulatory trends they see for E&L studies in the future.
If you’re interested in attending, please register here.
Dr. Mark Jordi
President and CEO, Jordi Labs
Dr. Ted Heise
VP Regulatory and Clinical Services, Med Institute
Director and Principal Toxicologist, Risk Science Consortium