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As the New Year is fast approaching, we asked members of our Life Sciences team to share their predictions of what will be the key issues...
Cortex - Life Sciences Insights
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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)...
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On 30 October 2024, Medicines Australia (MA) formally adopted a new edition (Edition 20) of the MA Code of Conduct (MA Code), which will...
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The Spanish Ministry of Health has made public this week the draft Royal Decree establishing the conditions for the elaboration and...
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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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Governments around the world continue to place corporate crime at the top of their enforcement agendas, and the United Arab Emirates...
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On 21 March 2024, the second stage of Australia’s vaping reforms bill was introduced before the Australian Parliament. The Therapeutic...
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The Australian Federal Government has announced the first stage of Australia’s vaping reforms, which are set to commence on 1 January...
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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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On June 1, 2023, China’s Ministry of Science and Technology (the “MOST”) issued the Implementation Rules of Administrative Regulations on...
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On 12 October 2023, EU Foreign Subsidies Regulation (“FSR”) filings to the European Commission (“EC”) became mandatory. In addition to...
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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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EU Commission Proposal On 5 July 2023, the European Commission proposed a new legislative initiative regarding plants obtained by...
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Cannabis for adult-use is no longer a clandestine indulgence anymore, but a thriving industry in certain countries globally. Germany...
