THE NATIONAL COORDINATION CENTRE OF ETHICS COMMITTEES APPROVES NEW DOCUMENTS IN ANTICIPATION OF THE APPLICATION OF REGULATION (EU) NO 536/2014

The National Coordination Centre of Ethics Committees for Clinical Trials on Medicinal Products for Human Use and Medical Devices has published documents in anticipation of the implementation of Regulation (EU) No 536/2014 and available at the following link: https://www.aifa.gov.it/-/il-centro-di-coordinamento-nazionale-dei-comitati-etici-approva-nuovi-documenti-in-vista-dell-applicazione-del-regolamento-ue-n.-536/2014 The approved documents can be viewed in the related documents section ... Leggi

CLINICAL RESEARCH: TOWARDS NEW REGULATORY FRAMEWORKS

CLINICAL RESEARCH: TOWARDS NEW REGULATORY FRAMEWORKS The Fondazione IRCCS Policlinico San Matteo is organising the event entitled: CLINICAL RESEARCH: TOWARDS NEW REGULATORY CONTEXTS – The regulation on clinical trials and medical devices: impacts and opportunities”. 15 October 2021 Conference Hall – Ancient Village of the Certosa of Pavia from 9:30 ... Leggi

REQUIREMENTS FOR CRA CERTIFICATION DURING THE PANDEMIC REGIME

AIFA, following the solicitation of AICRO and Assomonitor, undertakes to amend the requirements for the certification of CRAs during the pandemic regime. In view of the difficulties in accessing experimental centres for CRAs in training, AIFA revises the number of in-person visits to 3 and remote visits to 7 until ... Leggi