The Regulatory Interplay Between Medical Devices And Medicines – Focus On Companion Diagnostics In The EU And U.S.(Part 2) The Allen & Overy Podcast Archive podcast

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Financial Services Business Allen Overy

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The regulatory interplay between medical devices and medicines – focus on companion diagnostics in the EU and U.S.(Part 2)

1y ago 12:51

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Companion diagnostics are classed in the U.S. and in the EU as medical devices, usually in-vitro medical devices (IVDs). They are a class of products which are rapidly gaining in importance, particularly in treating patients with cancer. About one third of marketing authorisations in the field of oncology in the EU between 2010 and 2020 required a diagnostic test for patient identification. The Global Oncology Companion Diagnostic Market Size was valued at 2.2 billion in 2019. In this podcast, Sapna Palla, Tine Carmeliet and Rafi Allos discuss the regulation of IVDs in the EU and the U.S. and how they are authorised in these jurisdictions.

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117 episoder

#Financial Services #Business #Allen Overy

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The regulatory interplay between medical devices and medicines – focus on companion diagnostics in the EU and U.S.(Part 2)

The Allen & Overy Podcast archive

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published 1y ago

Del

MP3•Episode hjem

Indhold leveret af Allen & Overy and Amp; Overy. Alt podcastindhold inklusive episoder, grafik og podcastbeskrivelser uploades og leveres direkte af Allen & Overy and Amp; Overy eller deres podcastplatformspartner. Hvis du mener, at nogen bruger dit ophavsretligt beskyttede værk uden din tilladelse, kan du følge processen beskrevet her https://da.player.fm/legal.

Companion diagnostics are classed in the U.S. and in the EU as medical devices, usually in-vitro medical devices (IVDs). They are a class of products which are rapidly gaining in importance, particularly in treating patients with cancer. About one third of marketing authorisations in the field of oncology in the EU between 2010 and 2020 required a diagnostic test for patient identification. The Global Oncology Companion Diagnostic Market Size was valued at 2.2 billion in 2019. In this podcast, Sapna Palla, Tine Carmeliet and Rafi Allos discuss the regulation of IVDs in the EU and the U.S. and how they are authorised in these jurisdictions.

… continue reading

117 episoder

#Financial Services #Business #Allen Overy

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