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Regulatory MDCG updates Q&A on vigilance terms under MDR and IVDR On 11 November 2024, the Medical Device Coordination Group (MDCG)...
Cortex - Life Sciences Insights
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Introduction In our second Network and Information Systems Directive (NIS2 Directive or Directive) article, we discuss the significant...
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Regulatory AIFA updates Guidelines for the classification and conduct of observational studies on medicines On 20 August 2024, the...
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The use of artificial intelligence (‘AI’) systems in the pharmaceutical and healthcare sectors is growing exponentially, with...
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Introduction On March 23rd, 2023, the Enlarged Board of Appeal of the EPO issued the long-awaited decision concerning the concept of...
This week our Life Sciences team published the first edition of its Cross-border Guide to Clinical Trials and Privacy. The Guide will...
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In recent years, China has introduced a number of major data protection laws, including the Personal Information Protection Law (PIPL)...
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The UK’s Department for Health and Social Care (“DHSC”) has published a major strategy document (‘Data saves lives: reshaping health and...
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What is the European Health Data Space? On 3 May 2022, the EU Commission published a draft Regulation on the European Health Data Space...
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After the publication of the Code of conduct regulating the processing of personal data in the field of clinical trials and other...
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The Spanish Data Protection Commissioner (“AEPD”) has recently approved the “Code of conduct regulating the processing of personal data...
In response to a set of questions from the European Commission, the European Data Protection Board (“EDPB”) has published some high level...
