Portolano Cavallo

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31 Mar
National Platform for Telemedicine: Agenas launches a request for proposals to set up a Public/Private Partnership
Taking advantage of the resources made available under the Next Generation EU Plan, the Italian Government has decided to launch a project for the planning, implementation and delivery of IT services facilitating access to the National Platform for Telemedicine.
EU Medical Device Coordination Group (MDCG) approves “Guidance” on appropriate surveillance of devices covered by certificates according to the MD Directives, under the transitional provisions of Article 120(3) of the MDR.
21 Mar
Published Decree of Health Ministry identifying the ethics committees of national significance for clinical trials of medicinal products and medical devices
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.
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
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.
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 news, insights 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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September 21, 2022
Payback for medical devices: Decree quantifying the exceeding of the expenditure ceiling for medical devices at national and regional level for the years 2015, 2016, 2017 and 2018 published ...
September 1, 2022
The 2021 annual law for market and competition addressing, as to the healthcare sector, reimbursement of drugs, intermediate distribution, patent linkage and institutional accreditation of p...
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...
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