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Portolano Cavallo Life Sciences Blog
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 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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August 4, 2021
Clinical Trials Regulation: EMA and European Commission confirmed that the Clinical Trials Information System (CTIS) will go-live on January 31, 2022
June 25, 2021
Clinical trials: EMA launches public consultation on draft guideline for using computerized systems and electronic data
June 9, 2021
The Medical Device Coordination Group endorsed new FAQ on the European Medical Device Nomenclature (EMDN), that aims at supporting the functioning of the European database on medical devices...
May 25, 2021
The Italian Data Protection Authority published guidelines on the role of the Data Protection Officer in public entities: important news for hospitals and healthcare facilities
May 4, 2021
European Health Union: Commission publishes open public consultation on the European Health Data Space
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