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23JanThe Italian Parliament approved Law no. 6 of January 13, 2023, setting forth new provisions applicable to distribution agreements in the automotive industryOn January 19, 2023, Italian Law No. 6 of January 13, 2023, containing amendments to Italian Law No. 108 of August 5, 2022, entered into force.Article filed under: Automotive & Mobility
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16JanUrban air mobility: Implementation of the U-space regulatory packageWithin the context of legislative developments on urban air mobility, as of January 26, 2023, the three implementing regulations adopted by the European Commission in April 2021 will come into force in the European UnionArticle filed under: Automotive & Mobility
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21DecClinical trials and sanctions in relation to Regulation 2014/536, national rules, and contract standardsThe European rules on drug trials do not include provisions for sanctions, but instead leave it up to Member States to outline an effective sanctioning framework.
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1DecReuse of personal data for research purposes in light of the most recent guidelines from the GaranteIn the context of clinical studies, companies are concerned about the legal conditions for use for research purposes of previously collected personal data, including data from third parties.
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20OctIRCCS reform: Upcoming changes with regard to researchThe regulation of Scientific Institutes for Research, Hospitalization, and Health Care (“Istituti di Ricovero e Cura a Carattere Scientifico,” “IRCCS” or “Institutes”) is undergoing a major transformation in Italy.
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21SepDecentralized clinical trials: The current scenario and forthcoming European guidelinesOn August 30, the European Commission (EC), heads of medicines agencies (HMAs), and European Medicines Agency (EMA) published the 2022-2026 work plan for the Accelerating Clinical Trials in the EU (ACT EU) initiative.
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5AugItalian amendments on automotive distribution agreementsOn August 5, 2022, the Official Journal published Italian law no. 108, converting Law Decree no. 68/2022, which contains urgent provisions for the safety and development of infrastructure, transport, and sustainable mobility, as well as for major events and for the functionality of the Ministry of Sustainable Infrastructure and Mobility.Article filed under: Automotive & Mobility
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2AugTrasparent and predictable working conditions: The new perspective from EU Directive 2019/1152On July 29, 2022, Decree No. 104 of June 27, 2022 implementing EU Directive 2019/1152 on transparent and predictable working conditions (hereinafter referred to as the “Transparency Decree”) was published in the Gazzetta ufficiale, and it will take effect on August 13, 2022.Article filed under: Labour and Employment
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25JulEuropean Health Data Space: Early indications of the future of circulation of health information in the European UnionLa Commissione Europea ha presentato una proposta di Regolamento dello spazio europeo dei dati sanitari: cosa contiene, le novità su uso primario e secondario dei dati, la piattaforma dedicata e le authority nazionali, il legame con il PNRR
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13JulVertiports: The backbone of urban air mobilityStep by step, the dream of using aircraft to rise above urban areas and avoid traffic is becoming a reality. However, the development of infrastructure for urban air mobility (“UAM”) will be crucial to industry growth.Article filed under: Automotive & Mobility
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