IRIS, new online platform for scientific advice

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:

  • human medicines:
    • Initial and…

MHRA Guidance regarding Brexit for industry and organisations to follow from 1 January 2021

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.

EMA publishes new Trial Master File (TMF) guideline for consultation

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…

CCMO presents Annual Report 2016

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…

Dutch Government wants European Medicines Agency to relocate to the Netherlands

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…