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
Clinical trials: new rules for conflict of interests
The regulation on conflict of interest in clinical trials was recently amended by Article 11-bis of Law Decree No. 34 of May 19, 2020 (Decreto Rilancio), as amended by Law No. 77 of July 17, 2020.
14
Oct 20
Clinical trials: National Coordination Center of Ethics Committees issues Guidelines for the collection of informed consent
The National Coordination Center of Territorial Ethics Committees for clinical trials on medicines and medical devices (“National Coordination Center”) has drawn up guidelines for the collection of informed consent (“Guidelines”) for participation in clinical trials, pursuant to Legislative Decree No. 211 of June 24, 2003 and Regulation (EU) 536/2014.
12
Oct 20
Remote clinical trials: from emergency to new normal
This article first appeared on the website of the Healthcare and Life Sciences Law Committee of the Legal Practice Division of the International Bar Association, and is reproduced by kind permission of the International Bar Association, London, UK. © International Bar Association.
9
Apr 20
AIFA: latest indications for "remote" clinical trials during the COVID-19 health emergency
On April 7, 2020, the Italian Medicines Agency (“AIFA”) provided guidance on the management of clinical trials in light of the restrictive measures adopted by the Government against the COVID-19 pandemic.
