Clinical Trials Regulation: EMA and European Commission confirmed that the Clinical Trials Information System (CTIS) will go-live on January 31, 2022
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Jul 21
Portolano Cavallo announces the appointment of Elisa Stefanini as partner
Portolano Cavallo is pleased to announce that attorney Elisa Stefanini, who has been with the firm since 2017, has been promoted from counsel to partner.
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Jul 21
Artificial intelligence and medical devices: The potential impact of the proposed Artificial Intelligence Regulation on medical device software
The recent proposal for a regulation on artificial intelligence (the Artificial Intelligence Regulation) might add a new piece to the regulatory puzzle governing medical device software and other medical devices that incorporate software based on AI algorithms.
Clinical trials: EMA launches public consultation on draft guideline for using computerized systems and electronic data
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Jun 21
The role of the DPO in the public sector: New guidance from the Italian Data Protection Authority
On May 24, 2021, the Italian Data Protection Authority published on its website “Guidance on designation, position and tasks of the Data Protection Officer in the public sector”.
11
Jun 21
Italian Competition Authority investigates orphan drug manufacturer (Leadiant) for excessive pricing
In October 2019, the Italian Competition Authority launched an investigation into abuse of dominance pursuant to Article 102 TFEU against the Leadiant group in connection with the marketing in Italy of the “orphan” drug Chenodeoxycholic Acid Leadiant, used to treat an ultra-rare disease.
