21
Dec 22
Clinical trials and sanctions in relation to Regulation 2014/536, national rules, and contract standards
The European rules on drug trials do not include provisions for sanctions, but instead leave it up to Member States to outline an effective sanctioning framework.
On 13 December 2022, EMA, European Commission and HMA jointly adopted a recommendation paper on the introduction of decentralised elements in the conduct of Clinical Trials in the EU/EEA
5
Oct 22
Decentralized clinical trials: The current scenario and forthcoming European guidelines
On August 30, the European Commission (EC), heads of medicines agencies (HMAs), and European Medicines Agency (EMA) published the 2022-2026 work plan for the Accelerating Clinical Trials in the EU (ACT EU) initiative.
6
Jul 22
News on the reorganization of Ethics Committees: Latest updates
In the past few months great strides have been made to establish the national ethics committees envisaged by Law No. 3 of 2018 (the “Lorenzin Law”), which were supposed to be identified by the Ministry of Health within sixty days of the Lorenzin Law taking effect.
6
Jul 22
Clinical trial contracts: What the new NCCEC models provide
On May 31 of this year, the National Center for the Coordination of Ethics Committees updated its model drug and medical device trial contracts. They are the benchmark for regulating the relationships between sponsors, CROs, and research centers involved in clinical trials.
6
Jul 22
<!--:it-->Draft EMA guidelines on transparency in clinical trials: Protecting commercially confidential information<!--:-->
On April 7, 2022, the EMA published draft guidelines on the transparency of information uploaded to the Clinical Trial Information System for the specific purpose of giving operational guidance on the management of commercially confidential information and personal data
