When ? The 4th of November from 15.00 till 16.30 CEST
Substances have already been the topic of a previous UNICOM Community of Expertise in August 2021 and this is not a surprise as substances form one of the three pillars of medicinal product identification. Much progress has been achieved in the last twelve months. In December 2021, we have announced that the cleansing of chemichal sustances was completed and in March 2022 EMA published the first release on its website. We believe it is now time to share the results with you and to focus in particular on the system created to manage substances: the EU Substance Registration System (EU-SRS). This is a specific task of the WP2 UNICOM in which CBG – The medicines Evaluation Board in the Netherlands- plays a prominent role.
The EU-SRS team will share with you how the different substance types are handled in EU-SRS in relationship to both structure and fields. Do not miss thus this deep dive into the working of EU-SRS where will explore how Chemicals, Polymers, Proteins and Vaccines are handled in EU-SRS. You will be provided with real examples of European substances records and we will explain some of the key choices made in building these records in EU-SRS.
We are confident that this will provide a good insight in the capabilities of EU-SRS for use by the European regulatory network, after go-live of the system.
The presenters will be Annet Rozema, Mirjam Keulen & Marcel Hoefnagel from CBG, The Netherlands,
Moderation will be done by:
Christian Hay (UNICOM WP 1, ISO/TC 215 WG6)
Robert Stegwee (UNICOM WP 1, CEN/TC 251)