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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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In recent years, there has been an upward global trend in the implementation of new legal measures aimed at addressing pay transparency....
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The implications of the recent Illumina/Grail Judgment Executive Summary In a landmark EU judgment, on 3 September 2024, the Court of...
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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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Download a copy of our July monthly briefing, which covers key updates and insights in the following areas: Medicinal products;Medical...
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It has been just over three years since the respective notification procedure to the European Commission (reported here), the Portuguese...
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Since 2006, when the Medicines Code was approved in Portugal, marketing authorisation holders had to include the retail selling price of...
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Executive Summary Combination therapies involve the use of two or more separate medicines in combination to treat a disease. It can be...
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It is currently intended that the Provider Selection Regime (PSR) will come into force on 1 January 2024. The PSR Regulations are a new...
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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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Download a copy of our September monthly briefing for Poland, which covers key updates and insights in the following areas: Medicinal...
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Cannabis for adult-use is no longer a clandestine indulgence anymore, but a thriving industry in certain countries globally. Germany...
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On the 1 April this year, amidst storm clouds gathering above the NHS in the form of staffing strikes, record waiting times and chronic...
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The Czech government has announced its plan to introduce a highly regulated cannabis market in the Czech Republic. Currently, cannabis is...
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In this episode of At the Intersection of Sciences and Law Podcast Series, in light of the recent publication of our Cross-border Guide...
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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...
