Euro Convergence Day 3: AI's regulatory framework, the future of ATMPs, and more

Regulatory NewsRegulatory News | 11 May 2021 |  By 

As Euro Convergence 2021 draws to a close, the European regulatory affairs community will gather virtually to hear updates on artificial intelligence and cell and gene therapies, and to explore how post-marketing surveillance will change in the upcoming years.
Use of artificial intelligence (AI) is seeping into more and more corners of healthcare, and those working in medical devices need to know how regulators address these technologies. Pat Baird, a senior regulatory specialist at Philips, will lead a Wednesday session that brings together compliance and regulatory specialists to provide updates and expertise.
Together with Loganathan Kumarasamy of Zifo RnD Solutions and Alexander Friedman, also of Philips, Baird will walk attendees through the international regulatory and compliance landscape for AI. Presenters will point out the considerable overlap between different fields that make use of advanced mathematical and computing techniques to solve diagnostic, data management, research and analytical problems in health care.
Baird and his colleagues will review the history of regulatory oversight of AI in health applications, bringing attendees to the current day to share the approach the US Food and Drug Administration (FDA) and EU are taking to fit AI into the medical device regulatory framework.
The regulatory future of such advanced therapy medicinal products (ATMPs) as chimeric antigen receptor T-cell (CAR-T) therapies will benefit from academia’s input, as ethical issues may leapfrog ahead of regulatory frameworks.
Also on Wednesday, Orin Chisholm of the University of South Wales, Sydney, will review ATMP regulatory frameworks that the FDA, the European Medicines Agency (EMA) and Japanese, Chinese and Australian regulators have set forth to date.
In the same session, Lutz Uharek, a hematologist and cell and gene therapy specialist at Berlin’s Charité hospital, will explore the tension between the academic roots of cell and gene therapies and the need for enhanced quality assurance that commercialization of these technologies requires.
Uharek will make the case that academia and industry, together with health care providers, should collaborate more closely and form alliances earlier in the drug development process.
Addressing post-market surveillance in the drug and device world means knowing the ins and outs of the requirements for ISO 14971:2019, which requires post-production information to feed into the product risk management process.
In a session led by Robert van Boxtel, principal consultant at Alphen a/d Rijn, the added complexities of the EU’s new Medical Device Regulations (MDR) and In Vitro Device Regulations (IVDR) will be set forth, since MDR and IVDR requirements are more stringent still. The panel will guide attendees through how ISO/TR 20416, published late in 2020, relates to post-marketing surveillance system laid out by MDR.
RAPS Euro Convergence 2021


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