ARTICLES BY JOHN GIANTSIDIS
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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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![Cyber Alert GettyImages-1185282377]( "The Clinical Trial Sponsor’s Roadmap To Avoid EMA (Cyber) Perdition")
The Clinical Trial Sponsor’s Roadmap To Avoid EMA (Cyber) Perdition3/1/2022Clinical trials are one of the sectors most vulnerable to cyberattacks. In the European Medicines Agency (EMA)'s Guideline on computerized systems and electronic data in clinical trials, the EMA goes beyond the traditional software validation and data integrity expectations. It sets requirements and expectations pertaining to user management and ongoing security measures.
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.