13-10-2020 / / Branche
Starting with 19th of October 2020, Marketing Authorization Holders of human and veterinary medicines should use EMA’s IRIS Regulatory & Scientific Information Management Platform in order to request scientific advice regarding the study design.
The following type information may be requested via IRIS:
03-09-2020 / / Branche
MHRA has just issued guidance regarding post Brexit period and clinical trials, devices, licensing, importing and exporting, IT systems, pharmacovigilance and paediatrics.
17-04-2017 / Daniela van 't Ent - Ifrim / Branche
The European Medicines Agency (EMA) has published on 12/04/2017 the draft version of new guideline “on good clinical practice compliance in relation to trial master files” (TMF). This document includes and updates the guidance issued previously in the EMA draft…
22-03-2017 / Daniela / Branche
The protection of human subjects involved in clinical research represents this year's main topic in the annual report from the CCMO.
In this report CCMO explains its view on the role and importance of human subjects involved in medical research. The…
25-02-2017 / Daniela van 't Ent - Ifrim / Branche
The Netherlands has applied to host the European Medicines Agency (EMA) which is based curently in London. However, EMA will need to relocate to another European country when the United Kingdom leaves the EU. Health minister Edith Schippers and foreign…