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19JunPatient Support Program in digitale, come farlo bene e a normaAnche in seguito all’emergenza, i Patient Support Program stanno trovando ampia diffusione. Ciò rende necessario un intervento normativo che guidi gli operatori del settore nello sviluppo dei programmi, soprattutto in caso di PSP digitali. Nel frattempo, il Codice Deontologico di Farmindustria può essere assunto come guida
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12JunTrial clinici “a distanza”, un investimento a prova di futuroLe misure eccezionali messe in campo da Aifa durante l’emergenza fanno da apripista per nuovi modelli più efficienti. Dal monitoraggio centralizzato all’adozione di tecnologie per la source data verification, ecco gli strumenti cardine per spingere una completa digitalizzazione del processo
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11JunAcquisitions of companies involved in the medical devices business fall under the Italian foreign investment controlMore than 2 months ago the Italian Government issued certain measures with the purpose of expanding its power to veto or impose conditions on acquisitions of, or other transactions involving, Italian targets operating in certain strategic sectors.
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11JunVenture Capital watch: how COVID-19 is affecting and will affect VC transactions with a specific focus on the life sciences and healthcare sectorsThe COVID-19 outbreak is affecting VC transactions all over the world. Challenges but also opportunities may arise in sectors that will shape the post–COVID-19 world.
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11JunMasks, disinfectants, and serological tests: regulatory issues relating to products to be used in phases 2 and 3 of the emergency periodAfter the lockdown, for correct management of phases 2 and 3, products such as masks and disinfectants become even more essential in containing and preventing the spread of COVID-19.
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9JunItalian Competition Authority approves two emergency cooperation projects: one for joint distribution of surgical masks and one common moratorium scheme on consumer lendingFor the first time the Italian Competition Authority applied the communication of April 24, 2020, on cooperation agreements in the context of the COVID-19 outbreak. The two cooperation projects concern the joint distribution of surgical masks and a common moratorium scheme on consumer lending.
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29MayCOVID-19 emergency and processing of health data for scientific research purposesThe Italian version of this article was first published on Diritto 24 - Il Sole 24 Ore. The health emergency due to the spread of COVID-19 has made the need to correctly manage the processing of health data for scientific research purposes even more topical.
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9AprCOVID-19 emergency: increasingly dematerialized prescriptionsBreaking news about e-prescriptions: Ordinance 651/2020 and Ministerial Decree of March 25, 2020 introduced alternative tools to paper memorandum of e-prescriptions.
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9AprMedical Devices Regulation: EU Commission proposes a one year postponement of the application dateThe European Commission adopted a proposal to postpone the date of application of Medical Device Regulation by one year and deviate from the conformity assessment procedures in cases of emergency.Article filed under: Life Sciences
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9AprAIFA: latest indications for "remote" clinical trials during the COVID-19 health emergencyOn April 7, 2020, the Italian Medicines Agency (“AIFA”) provided guidance on the management of clinical trials in light of the restrictive measures adopted by the Government against the COVID-19 pandemic.
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