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15 Sep 23
AI and machine learning in the medicine lifecycle: EMA publishes first draft of reflection paper
The first draft of EMA’s “Reflection paper” contains the authority’s latest considerations on the application of AI and machine learning methods in each phase of the medicinal product lifecycle.
8 Sep 21
Artificial Intelligence and Machine Learning in Clinical Trials: Regulatory attempts by European and national authorities
In the last few years, use of Artificial Intelligence and Machine Learning systems in the performance of Clinical Trials has increased.
Clinical Trials Regulation: EMA and European Commission confirmed that the Clinical Trials Information System (CTIS) will go-live on January 31, 2022
Clinical trials: EMA launches public consultation on draft guideline for using computerized systems and electronic data
15 Oct 20
EMA launches public consultation on the draft Guideline concerning registry-based studies
Last September, the EMA published its draft Guideline on registry-based studies (“Guideline”). This draft Guideline is currently open for public consultation: stakeholders may post comments until December 31, 2020.
17 Oct 19
The ranitidine case: a test for the new class action?
On September 20, 2019, the Italian Medicines Agency (AIFA) ordered the withdrawal of several batches of medicine containing Ranitidine, which is produced by the pharmaceutical laboratory SARACA LABORATORIES LTD in India.
Welcome to the Portolano Cavallo Life Sciences blog focusing on legal development and key legal issues affecting the Life Sciences-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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October 6, 2023
CBD products: the Administrative Court suspended until October 24 the recent Decree of the Italian Ministry of Health listing cannabidiol for oral use among narcotic drugs, due to the lack o...
October 4, 2023
The Guidelines for regulating contractual relations between universities and research institutes and private sponsors were adopted by the relevant Italian Ministries following the amendment ...
September 21, 2023
CBS products: from September 20th, compositions for oral administration of cannabidiol obtained from Cannabis sativa extracts shall be considered as narcotic drugs in Italy, as they have bee...
July 27, 2023
Payback on medical devices: Italian government announces extension of payment deadline to October 30, 2023
July 21, 2023
On July 21, 2023, the Italian Ministry of Health published new guidelines on health advertising of self-medication drugs (OTC) and non-prescription drugs (SOP), including advertising on new ...
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