Wednesday, May 25, 2022 at 11am EDT|8am PDT|5pm CEST|4pm BST n 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 for both drugs and devices. Join our panel of industry experts to discuss these changes and to learn the direction E&L studies may take in the future.
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.
Key Learning Objectives:
Who Should Attend:
Dr. Mark Jordi
President and CEO
Dr. Mark Jordi is the President of Jordi Labs, a position he has held since 2006. During his tenure, Jordi labs has experienced 16 years of consecutive growth and has become a leader in the polymer analysis industry. Jordi Labs provides over 2,000 analyses annually and offers more than 60 analytical techniques serving a wide range of industries including the chemical, pharmaceutical, and medical device industries. Dr. Jordi completed his BS in chemistry at Olivet Nazarene University and his PhD at the University of Connecticut in the materials science division. His primary interests include development of improved strategies for identification and quantification of extractables and leachables as well as chromatographic and mass spectrometric analysis. Dr. Jordi is also an inventor and has developed a number of novel chromatographic stationary phases, some of which are patented.
Dr. Ted Heise
VP Regulatory and Clinical Services
Ted Heise supports regulatory and clinical study strategies for Med Institute clients. His BS in chemistry is from the University of Nebraska, and his PhD in analytical chemistry is from Iowa State University. Dr. Heise is an expert in ISO and USP committees for consensus standards that govern biocompatibility testing of medical devices and drug packaging, currently serving as convenor of the working group for ISO 10993-18 on chemical characterization.
Director and Principal Toxicologist
Risk Science Consortium
Ron Brown is a toxicologist who recently retired from the US FDA and currently directs a small company, Risk Science Consortium, LLC. At the FDA, Ron was the senior toxicologist responsible for developing and reviewing toxicological risk assessments of extractable and leachable (E&L) compounds released from medical devices. While at the FDA, he served in a number of leadership roles in standards development organizations, notably, as convener of ISO TC194 WG11, which is responsible for the development and revision of the ISO 10993-17 standard.