Quality Assurance(QA)




Inspection readiness


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…

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…

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…