27-08-2020 / Daniela van 't Ent - Ifrim / Legislation
TranspariMED and Health Action International (HAI) have recently reported that Dutch institutions that run clinical trials violate the European transparency rules but failing to report clinical trials results in the public registry.
Only 1 out of 23 universities/research institutes has adequately…
14-07-2020 / Daniela van 't Ent - Ifrim / Legislation
EMA board has announced that the implementation of the Clinical Trials Information system (CTIS) would be December 2021. The CTIS is the portal for the Clinical Trials Regulation 536/2014.
Recently, EMA has released the first newsletter on the topic which gives…
18-06-2020 / Daniela van 't Ent - Ifrim / Legislation
Clinical Trials Information System (CTIS), initially published in May 2014, is expected to go live in December 2021. From that moment on, the EU Regulation on research with a medicinal product will apply as well. CTIS is built for the implementation…
29-05-2020 / Daniela van 't Ent - Ifrim / Legislation
On 26.05.2020 CCMO has updated their recommendations for the conduct of clinical research at the time of restrictive measures due to the coronavirus. The PDF document can be downloaded here.
28-04-2020 / Daniela van 't Ent - Ifrim / Legislation
The Commission has published guidance to ensure that clinical trials can continue taking place in the EU during the COVID-19 pandemic. The aim is to mitigate the disruption of clinical research in Europe and the negative effects of the pandemic, without…