21
Nov
The Dabus case: Artificial intelligence cannot be designated as the inventor in a patent
Artificial intelligence (AI) plays a fundamental role in the life sciences sector. AI offers the opportunity to facilitate various processes. For example, it can be used to analyze and process large quantities of health data that in turn may facilitate the discovery of new drugs, improve diagnostics, and customize treatments. It also can be used to automate laboratory processes and manage clinical trials, saving time and resources.
21
Nov
Transparency in clinical trials: Revised transparency rules take effect
The revised transparency rules (“Revised Rules”) for the Clinical Trials Regulation (CTR) and its Clinical Trials Information System (CTIS), issued by the EMA in October 2023, took effect on June 28, 2024, with the launch of a new version of the dedicated portal.
21
Nov
New AIFA guidelines on simplification and decentralization of clinical trials
As mentioned in our other article, this article deals with the guidelines approved by the AIFA on the same day as those on observational studies. They were also published in the Italian Official Gazette on August 20, 2024. The guidelines concern simplification and decentralization of clinical trials of medicines.
21
Nov
New AIFA guidelines on observational studies and decentralized clinical trials: Digital tools increasingly in focus
The AIFA issued two new guidelines, focusing, respectively, on observational studies and clinical trials for medicinal products.
20
Nov
Anti-counterfeit drugs: Italy must comply with EU Regulation 2016/161 by February 9, 2025
Measures to combat counterfeit drugs work to prevent such drugs from entering the European supply chain. Delegated Regulation (EU) 2016/161 introduces new rules to halt counterfeit drugs from entering the European market and includes digital tools. As of February 9, 2025, Italy will have to comply with the provisions of the regulation, so there is not much time left to get in line with the new measures.
11
Nov
Transparency in clinical trials: Revised transparency rules take effect
The revised transparency rules (“Revised Rules”) for the Clinical Trials Regulation (CTR) and its Clinical Trials Information System (CTIS), issued by the EMA in October 2023, took effect on June 28, 2024, with the launch of a new version of the dedicated portal.
