AMRI’s John Iannone Named US Expert to ISO Technical Committee

Leveraging the multidisciplinary expertise of AMRI’s technical team, I will continue to propose expert solutions to the guidelines in development and to our customers, current and future.

AMRI, a global contract research, development and manufacturing organization working with the life sciences industry to improve patient outcomes and quality of life for more than 25 years, today announced that John Iannone, director of extractables/leachables & impurities, has been named a US expert to the International Standards Organization/Technical Committee 194: Biological and Clinical Evaluation of Medical Devices.

Through this appointment, Mr. Iannone will have the opportunity to participate in global ISO committee meetings and specifically discussions surrounding the changing regulatory landscape of ISO 10993, a set of international standards for evaluating the biocompatibility of medical devices. In addition, as a nominated subject matter expert, Mr. Iannone will further influence product safety guidelines and regulations. Only persons nominated as subject matter experts and accepted by the chairs of the respective working groups are allowed to attend in the international annual meeting.

“More than ever before, it is critical to understand the complex science of extractable and leachable assessments, as the chemistry involved has significant effect on the safety of medicines and medical devices,” said Mr. Iannone. “With that knowledge, we can develop and implement expert solutions which adequately demonstrate safety and suitability of the many innovative products currently being introduced in the market. Through leveraging the multidisciplinary expertise of AMRI’s technical team, I will continue to propose solutions to the guidelines in development and to our customers, current and future. This is an exciting time and am thrilled to be a contributor to the industry overall.”

John Iannone serves as director of extractables/leachables (E&L) and impurities at AMRI. As a current candidate for board certification by the American Board of Toxicology (DABT), he ensures a strong tie to safety considerations in the AMRI E&L team. His areas of expertise include material qualification and biocompatibility, extractables and leachables,…

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