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
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.
20
Nov
AI and healthcare: A question of liability
Artificial intelligence (AI) systems of varying levels of sophistication are increasingly used in health care in conjunction with various medical services.
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.
