Decode the latest changes to ISO 10993 standards and shifting global regulations with Eurofins’ experts. From key updates to emerging trends and practical biocompatibility strategies, the Eurofins’ team will explain how to successfully navigate the new landscape of biocompatibility and chemical characterization testing.

During this webinar, you will learn:

• Key updates in the current FDIS of ISO 10993-1
• Insights into the FDA’s latest draft guidance on E&L, and chemical characterization
• Trends emerging in in vitro toxicology and how they’re reshaping testing
• Challenges faced during in vivo toxicology and to overcome them

Presenters:

	Andrew Blakinger Senior Manager Eurofins Medical Device Services
As Senior Manager, Andrew Blakinger leads the Chemistry and Extractables & Leachables Testing team for Eurofins Medical Device Services. He has more than 13 years of experience planning, managing, and conducting E&L studies for medical devices and delivery systems as well as pharmaceutical container closure systems and manufacturing equipment. Additionally, he previously oversaw Eurofins’ container closure integrity testing (CCIT) and compendial container testing team as well as their team in toxicological services.. He holds vast expertise and experience in ICP-OES testing and analysis by LC/MS. Andrew earned a B.A. in chemistry from Clemson University.
	Kimberly Ehman, PhD, DABT Head of Regulatory Toxicology Eurofins Medical Device Services
As Head of Regulatory Toxicology, Kimberly Ehman leads the biocompatibility consulting and toxicological risk assessment services for Eurofins Medical Device Services North America. She has more than 20 years of toxicology and medical device experience, with expertise in toxicological risk assessments for medical devices, food and beverage products, and electronic nicotine delivery systems. Prior to joining Eurofins, she was the Director of Regulatory Toxicology and Consulting at WuXi AppTec and has also held positions at Altria Client Services (Head of Regulatory Toxicology), Toxicology Regulatory Services (Consulting Toxicologist and Program Manager), and RTI International (Research Toxicologist for Developmental and Reproductive Toxicology and Neurotoxicology). She earned her PhD from McGill University in Montréal, Canada, and conducted her postdoctoral research at the US EPA, with a focus on developmental neurotoxicology. She has been a Diplomate of the American Board of Toxicology since 2009 and an active member of the Society of Toxicology (SOT) since 2005 and the American College of Toxicology (ACT) since 2010. She is currently the VP-elect for the Medical Device and Combination Product Specialty Section (MDCPSS) of SOT and serves as an expert on several US working groups for the ISO 10993 series of standards, including ISO 10993-1 (Evaluation and testing within a risk management process), ISO 10993-3 (Tests for genotoxicity, carcinogenicity, and reproductive toxicity), and ISO 10993-17 (Toxicological risk assessment of medical device constituents).
	Melissa Ellis Biocompatibility Study Director Product Safety Labs
As Biocompatibility Study Director for Product Safety Labs in New Jersey, Melissa Ellis is responsible for overseeing biocompatibility studies to assess the safety of medical devices, including but not limited to cytotoxicity, irritation, sensitization, acute systemic toxicity, pyrogenicity, hemolysis, and implantation. Her strong commitment to advancing biocompatibility science has contributed significantly to the laboratory’s growth within the medical device industry. With 13 years of experience, Melissa has established herself a s a key laboratory contact for biocompatibility testing. She collaborates closely with clients to ensure successful study execution, while supporting their efforts toward regulatory submission. Melissa holds a bachelor’s degree in laboratory animal science from Rutgers University.