ARTICLES BY JOHN GIANTSIDIS
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![GettyImages-1591787866-data-hacked-internet-IT]( "Life Sciences Cybersecurity Incident Management: The End-to-End Approach")
Life Sciences Cybersecurity Incident Management: The End-to-End Approach10/24/2024Life sciences companies are focusing on smart manufacturing, digital supply chain, and leveraging AI/ML. A good cybersecurity incident response plan can make the difference between a cybersecurity incident versus crisis.
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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.
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![red-wave]( "Are You Ready For The FDA's “Data Effect” Tsunami? 8 Steps To Prepare")
Are You Ready For The FDA's “Data Effect” Tsunami? 8 Steps To Prepare5/5/2021The FDA is moving forward with its Data Modernization Action Plan, the next leg of the Technology Modernization Action Plan. As such, you'll need to prepare yourself for the influx of questions, audits, observations, warning letters, and more. Here's what you can do to position yourself for success.
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.