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28MarDecentralized clinical trials: Recommendation paper for the implementation of uniform procedures in the European Union publishedOn December 13, the European Commission (EC), the Heads of Medicines Agencies (HMAs), and the European Medicines Agency (EMA) published a document entitled Recommendation paper on decentralised elements in clinical trials (“Recommendations”) to provide Member States further and more detailed guidance on the implementation of procedures for conducting trials outside of traditional clinical trial centers.
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8MarPortolano Cavallo invests in Private Equity with new partner Andrea GrittiIn the last two years, Portolano Cavallo has handled approximately 80 M&A transactions with double-digit revenue growth in recent years.Article filed under: Private Equity
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24FebVendita di farmaci online: perché in Italia “RxPass” di Amazon non potrebbe funzionareIn Italia, la vendita a distanza di farmaci soggetti a prescrizione medica è espressamente vietata dal Codice del farmaco, ma il “modello Amazon” si scontrerebbe con una significativa serie di limitazioni anche se riguardasse unicamente medicinali da banco. Ecco i nodi
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25JanHow Covid changed telemedicine in Italy: Current status and next stepsDurante e dopo la pandemia, la telemedicina è stata al centro di una serie di importanti interventi del legislatore. A questi si aggiungono ora i fondi del PNRR per 1 mld di euro. Tali risorse e il ruolo delle regioni nel garantirne l’implementazione saranno di fondamentale importanza.
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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.