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A much-awaited extension of the MDR transition period became effective today with the publication of Regulation (EU) 2023/607 in the...
Cortex - Life Sciences Insights
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On 31 January 2023, the new Clinical Trials Information System (CTIS) established by Regulation (EU) 536/2014 on clinical trials (CTR)...
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Our EU Life Sciences Regulatory team led by Marco de Morpurgo and Nicola Landolfi have produced a guide on EU Pharma & Medical Device...
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Today, the European Commission adopted a proposal for a new Regulation on standards of quality and safety for substances of human origin...
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In a note published on 2 March 2022, the Italian Medicines Agency (AIFA) confirmed that all pharmaceutical companies must, by no later...
Following an informal heads-up on 25 March 2020, today the European Commission adopted a proposed regulation to postpone by one year the...
On 1 January 2021, important transparency obligations provided for in the Code of Ethics of Confindustria Dispositivi Medici (the Italian...