ACT-EU is the stakeholder fora and groups within the European medicines regulatory network (EMRN)

Published by

A list of stakeholder fora and groups within the European medicines regulatory network that are involved in the clinical trial lifecycle. Detailed information is published on each group or forum, along with a visual representation of their interactions.

View this resource Bookmark this resource

In vitro diagnostics BIC Regulatory Guide

Published by Biomarker Commercialization (BIC) consortium

Research and Drug Development Biomarker IVD Biomarker Assay Development Regulatory

The BIC In Vitro Diagnostics Regulatory Guide introduces researchers and entrepreneurs to basic understanding of the regulatory process for CE mark of IVD diagnostics, along with the development of the project toward a clinical product

View this resource Bookmark this resource

EMA pre-submission meeting (Pre-MAA meetings)

Published by IRDiRC

Regulatory Affairs Marketing Authorisation EU Marketing Authorisation Road Map MAA Pre-Submission Regulatory MAA Submission

MAA Pre-submission meeting is not a mandatory meeting, however, it is strongly recommended as it is the final meeting before the registration (MAA submission) where the developer address product- specific legal, regulatory and scientific issues

View this resource Bookmark this resource

IMT Feedback

Did the IMT help you in finding the resource you needed?