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Portolano Cavallo Life Sciences Blog
3 Apr 19
Italian administrative court judgments on biosimilars
In the past two months, the Italian administrative courts issued two judgments on biosimilars that substantially confirmed the previous case law on the relevant subjects.
2 Apr 19
Patient disease registries: potential use for regulatory purposes
Public consultation on the discussion paper published by the European Medicines Agency (EMA) regarding the crucial role of patient disease registries in monitoring the safety of medicines is open until June 30, 2019.
1 Apr 19
Personal Data: new interpretative recommendations in Clinical Trials
On January 23, 2019, the European Data Protection Board (EDPB) published an opinion on the interplay between the Clinical Trials Regulation (CTR) and the General Data Protection Regulation (GDPR) regarding the processing of clinical trial data.
9 Feb 19
Italian government approves a draft legislative decree amending italian legislation on clinical trials
On February 14, 2019, the Italian Government approved a draft legislative decree, implementing Law no. 3/2018 which delegated the Government to take measures to reform the Italian legislation on clinical trials on medicinal products for human use, with the purpose, among other things, to prepare the Italian legal framework to the future application of the Clinical Trial Regulation (EU) 536/2014.
Welcome to the Portolano Cavallo Life Sciences blog focusing on legal development and key legal issues affecting the life sciences and healthcare industry.
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Our highly-ranked team of professionals will provide newsinsights and multidisciplinary commentary on the hottest and most recent regulatory, transactional and contentious aspects of the pharmaceutical, bio-tech, med-tech, food supplement and healthcare world with an eye on its digital transformation and technological developments.

This blog will be a place for focusing on digital health, telemedicine and artificial intelligence, as well as more traditional topics: from the protection of intellectual properties to performance of clinical trials, from the market access to advertising and competition issues, from internal and criminal investigations to M&A and venture capital transactions.

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July 19, 2022
Guidelines for the implementation of the Electronic Health Record (EHR) to ensure dissemination, uniformity and accessibility of the EHR at national level now published in the Official Gazet...
June 6, 2022
The National Coordination Centre for Ethics Committees published new draft agreements for conducting clinical trials on drugs and medical devices
April 27, 2022
EU Medical Device Coordination Group (MDCG) approves “Guidance” on the borderline between medical devices and medicinal products in order to support the uniform application of Regulation...
April 5, 2022
Electronic prescriptions: the current modalities of transmission from doctors to patients and from patients to pharmacies are extended until 31st December 2022
March 24, 2022
EU Medical Device Coordination Group (MDCG) approves “Guidance” on appropriate surveillance of devices covered by certificates according to the MD Directives, under the transitional prov...
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