06 Oct, 2022 New IFPMA/EFPIA guidance on social media and digital channels By Marco de Morpurgo Carlotta Busani The International Federation of Pharmaceutical Manufacturers and Associations (IFPMA) and the European Federation of Pharmaceutical...
20 Sep, 2022 Italian adapts national medical device framework to MDR and IVDR By Marco de Morpurgo Carlotta Busani Italy enacted legislation to adapt the national framework governing medical devices and in vitro-diagnostic medical devices to the MDR...
31 Jan, 2022 New EU Clinical Trial Regulation to take effect from today By Marco de Morpurgo Carlotta Busani Today, the new EU Clinical Trials Regulation (Regulation (EU) No 534/2014 – “CTR”) becomes applicable. The CTR introduces a unified...
25 Nov, 2021 Advertising of medical devices: Italian Ministry of Health confirms national pre-authorization requirement despite MDR By Carlotta Busani Marco de Morpurgo With Circular 0081386 dated 12 November 2021, the Italian Ministry of Health confirmed that the national pre-authorization requirements...
07 Oct, 2021 New Clinical Trial Rules in the EU: A Practical Overview of the Upcoming Regulation By Marco de Morpurgo Carlotta Busani With the upcoming application of the new EU Clinical Trials Regulation (‘CTR’), the conduct of clinical trials in the European Union...