ARTICLES BY JOHN GIANTSIDIS
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![FDA headquarter iStock-1213293784]( "FDA Seeks Input On AI Adoption In Drug Development And Manufacture")
FDA Seeks Input On AI Adoption In Drug Development And Manufacture6/13/2023The FDA released two discussion papers for consideration: Using Artificial Intelligence and Machine Learning in the Development of Drug and Biological Products and Artificial Intelligence in Drug Manufacturing. The papers identify current and potential areas for AI adoption.
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![GettyImages-1138358728]( "New EU Directive Marks Cybersecurity Regulatory Paradigm Shift For Bio/Pharma & Medical Devices")
New EU Directive Marks Cybersecurity Regulatory Paradigm Shift For Bio/Pharma & Medical Devices2/15/2023The EU's new Directive 2022/2555 on the Security of Network and Information Systems (“NIS2”) mandates cybersecurity risk management measures and reporting requirements for all segments of our industry, including labs; CROs and CDMOs; and manufacturers of APIs, bio/pharmaceuticals, and medical devices.
John Giantsidis
John Giantsidis is the president of CyberActa, Inc., a Boston-based boutique consultancy empowering medical device, digital health, and pharmaceutical companies in their data-driven digital, regulatory, cyber, and privacy endeavors. He is the vice chair of the Florida Bar’s Cybersecurity and Privacy Law Committee and a Cyber Aux with the U.S. Marine Corps. He holds a Bachelor of Science degree from Clark University, a Juris Doctor from the University of New Hampshire, and a Master of Engineering in Cybersecurity Policy and Compliance from George Washington University. He can be reached at john.giantsidis@cyberacta.com.