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12MayDrug advertising: New directions from EuropeEurope is not making any revolutionary changes when it comes to the advertising of medicines.
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26AprThe metaverse in healthcare: What are the legal implications?Di fronte a così tante opportunità, il diritto si interroga su quali possano essere gli strumenti per gestire e regolare il fenomeno del metaverso nella sanità.
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17AprDelivering drugs to the public outside a pharmacy via a third party: Considerations on a recent ruling by the Criminal Court of CassationIt’s official: Under certain conditions it is not an offense for drugs—including prescription drugs—to be received by and distributed to the public, potentially even outside the pharmacy channel.
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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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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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17MarThe new decree on non-profit studies: Data and results may now be soldOn February 16, 2022, more than two years later than planned, the Ministerial Decree of November 30, 2021, containing measures to facilitate and support the development of nonprofit clinical trials of medicinal products and observational studies, as well as to regulate the transfer of data and results of nonprofit trials for registration purposes, was finally published in the Official Gazette.
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