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Portolano Cavallo Life Sciences Blog
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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May 4, 2021
European Health Union: Commission publishes open public consultation on the European Health Data Space
April 22, 2021
Clinical Trial Regulation: Clinical trial EU Portal and Database, essential for the Clinical Trial Information System (CTIS), is now fully functional and on track to go live by 31 January 20...
January 19, 2021
Dematerialization of prescriptions: Ministerial Decree allowing e-prescriptions for drugs not reimbursed by the NHS has been published in the Italian Official Journal.
December 21, 2020
Telemedicine: Italian State-Regions Conference issues "National indications for the provision of telemedicine services" to implement telemedicine services in Italy
October 8, 2020
Ecommerce of medicinal products: according to the European Court of Justice, certain legislative restrictions imposed by the Member State where medicines are offered to public also apply to ...
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