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Portolano Cavallo Life Sciences Blog
3 Mar
Investing in biotech
At the end of last year, our partners Luca Gambini and Antonia Verna talked to Elizabeth Robinson, vice chairman of the board of Indaco Venture Partners, and Ciro Spedaliere, partner in Claris Ventures SGR S.p.A., about the last trends in venture capital investments in the biotech sector.
9 Feb
European Clinical Trials Regulation is now applicable: Recent updates
On January 31, 2022, EU Regulation 536/2014 on clinical trials of medicinal products for human use (“Clinical Trials Regulation” or “CTR”) finally went into effect more than seven years after its approval, but Italy is not yet ready for its application.
9 Feb
The new version of the Code of Ethics of the Italian association of pharmaceutical companies: Key developments
The Italian association of pharmaceutical companies (“Farmindustria”) released the new version of its Code of Ethics on January 19, 2022. Some of the main changes concern i) hybrid events (art. 3.7 bis); ii) activities that pharmaceutical companies are allowed to carry out for non-prescribing HCPs (art. 3.25); iii) information provided to the public (art. 3.26); iv) interactions other than drug promotion (art. 3.28); and v) Patient Support Programs (article 4.7).
7 Feb
Digitization of Instructions for Use: the European Commission has endorsed a new Implementing Regulation on the use of electronic instructions for use (eIFUs) of medical devices
On December 14 2021, the European Commission adopted a new Implementing Regulation (EU) 2021/2226 laying down rules for the application of Regulation (EU) 2017/745 of the European Parliament and of the Council relating to electronic instructions for use of medical devices.
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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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...
March 21, 2022
Published Decree of Health Ministry identifying the ethics committees of national significance for clinical trials of medicinal products and medical devices
February 23, 2022
Published Decree of Health Ministry providing measures to enhance no-profit clinical trials and to regulate transfers of data and results of no-profit studies for registration purposes
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