Annet Rozema

Project Manager EU-SRS at College ter Beoordeling van Geneesmiddelen - Medicines Evaluation Board (CBG-MEB)

Speaker

Annet Rozema is the Project Leader for the implementation of EU-SRS in Europe. She works as an independent contractor at the Medicines Evaluation Board (MEB) in the Netherlands.

EU‑SRS is the European Substance Registration System, making use of GSRS software developed under leadership of FDA/NCATS. In January 2023, EU-SRS went live and also the Substance Validation Group (SVG) was officially installed. EMA is responsible for hosting and maintaining EU-SRS, the SVG (an official HMA Working Group) is responsible for maintaining the substance data. In the remaining months of 2023, the team will continue with the roll-out of EU-SRS to colleagues of the European regulatory network.

As Project Leader for EU-SRS, Annet enjoyed the collaboration with (substance) experts of the NCAs and EMA as well as with the software developers. She collaborated with the various European national competent authorities, with EMA and FDA. Next to interacting with the regulators, she also involved UMC, and other non-regulatory stakeholders such as industry, and partners of the Unicom project in relation to substance management. Much was achieved by all parties involved, but there is most certainly more work to be done in the area of substance data management.