22
Nov
Medical research: Prior consultation with the Data Protection Authority is no longer required
Medical research is one of the areas most affected by rapid technological development and increased use of artificial intelligence (AI) systems.
21
Nov
The Dabus case: Artificial intelligence cannot be designated as the inventor in a patent
Artificial intelligence plays a fundamental role in the life sciences sector, offering the opportunity to facilitate various processes. However, such use also raises numerous ethical and legal questions that touch on responsibility, reliability, and the correct and legal use of data and information to train AI for new technical solutions.
21
Nov
Transparency in clinical trials: Revised transparency rules take effect
The major changes under the revised transparency rules for the Clinical Trials Regulation and its Clinical Trials Information System, issued by the EMA in October 2023, should lead to faster publication of key documents (including protocols) and should make the system easier to use.
21
Nov
New AIFA guidelines on simplification and decentralization of clinical trials
The AIFA approved guidelines concerning simplification and decentralization of clinical trials of medicines, on the same day as those on observational studies.
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.
