ICH GCP E6 (R3) draft

29-05-2023 / Daniela van 't Ent - Ifrim / Legislation

After it was issued almost 30 years ago and several minor additions were made in 2016, the revised guideline of ICH gCP E6 (R3) has been endorsed by ICH Expert Working Group on 19th May 2023. The draft document is available for…

Clinical Trials Regulation and the Clinical Trials Information System (CTIS) EMEA webinar

19-12-2021 / Daniela van 't Ent - Ifrim / Legislation

If you have missed the EMA webiner from 29NOV2021 regarding the upcoming CTIS, there is still a chance to acces the slides on EMA wesbite, here.

The scope of the webinar was to inform pharmaceutical companies and academic sponsors of clinical…

IRIS, new online platform for scientific advice

13-10-2020 / Daniela van 't Ent - Ifrim / 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…

UK as first country intending to have 100% of all clinical trials registered and their results reported in the public databse

16-09-2020 / Daniela van 't Ent - Ifrim / Legislation

UK’s Health Research Authority new initiative is to reach 100% of clinical trials registration, including CT results, into the public database. This is in order to offer transparency regarding clinical trials and facilitate information sharing among the researchers.

This strategy:

  • is based…

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

03-09-2020 / Daniela van 't Ent - Ifrim / Branche

MHRA has just issued guidance regarding post Brexit period and clinical trials, devices, licensing, importing and exporting, IT systems, pharmacovigilance and paediatrics.