28-04-2020 / Daniela van 't Ent - Ifrim / Legislation
The moment of ratification of the European Medical Device Regulation (EU no 2017/745 (MDR)) has been postponed by one year due to the corona crisis. The new date is 26 May 2021.
17-04-2020 / Daniela van 't Ent - Ifrim / Legislation
For more information see the original publication here, or the summaries made by QualityCR depending on the topic, as follows:
1. General considerations regarding ongoing CTs.
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…
17-04-2017 / Daniela van 't Ent - Ifrim / Legislation
The document below provides guidance on practical aspects of the implementation of the Agency's policy on the publication of clinical data for medicinal products for human use.
It covers guidance regarding:
- procedural aspects of the submission of clinical reports,
- the anonymisation of clinical…
03-04-2017 / Daniela van 't Ent - Ifrim / Conference
The World Conferences on Research Integrity provide a global forum for researchers, policy makers and research managers and administrators to share information and ideas for promoting integrity in research. They have produced many ideas for promoting integrity in research and…