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Portolano Cavallo Life Sciences Blog
3 Sep 17
New consent for processing sensitive data not needed after change of data controller: data protection thoughts and M&A
For the first time in Italy, a court has affirmed that when a data controller changes, there is no need to acquire new consent from the participants of a research project involving the processing of sensitive data, if the research purposes do not change.
2 Sep 17
Consultation opened on the new EMA’s concept paper on development and lifecycle of personalised medicines and companion diagnostics
The EMA has released for public consultation a concept paper on the development and lifecycle of personalised medicines and companion diagnostics.
1 Sep 17
EMA publishes the revised guideline on first-in-human clinical trials
The EMA, in cooperation with the European Commission and the representatives of the Member States of the European Union through the EU Clinical Trials Facilitation Group (CTFG), has revised its guidance on first-in-human clinical trials, to further help stakeholders identify and mitigate risks for trial participants.
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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March 20, 2023
Today, Regulation (EU) 2023/607 extending the transitional provisions for the placing on the market and putting into service of certain medical devices and in vitro diagnostic medical device...
January 31, 2023
Clinical trials: Ministry of Health signed off on decrees that (i) reorganize ethics committees and coordinate their activities, (ii) determine the single tariff for the authorization proced...
December 19, 2022
On 13 December 2022, EMA, European Commission and HMA jointly adopted a recommendation paper on the introduction of decentralised elements in the conduct of Clinical Trials in the EU/EEA
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...
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