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8 Sep
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.
4 Apr 19
A joint HMA and EMA taskforce analyzes the use of big data for the evaluation and monitoring of medicines
The Joint Big Data taskforce (“Taskforce”) between the Heads of Medicines Agencies (HMA) and the European Medicines Agency (EMA) was formed to describe the big data landscape from a regulatory perspective in order to ensure that the EU regulatory system has the capability and capacity to guide, analyze and interpret this data. Its work aims to facilitate the use of such data for the process of evaluation and monitoring of medicines by the regulatory authorities, analyzing the risk-benefit of medicinal products during their lifetime.
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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