The fifth trans-Atlantic workshop orgnanised in february 2023 was attended by representatives from UNICOM, US and EU regulators, biopharmaceutical manufacturers and technology vendors. Meeting discussions focused on global IDMP Implementation
The Swedish Medicinal Products Agency is leading the UNICOM work package dedicated to IDMP implementation within National Authorities competent for market authorisation. Sweden is currently ensuring the Presidency of the
Norway, Belgium, Greece, Italy, Finland and the USA collaborate with UNICOM to provide a limited (4 substances) but complete IDMP/FHIR data set.
The process consists in collecting Data “AS IS”, and doing a central standardization to EDQM, limited to the minimal attribute list (variables relevant for pilots) and limited to 4 single
It is celebration day today (Jan 25) in Amsterdam at EMA headquarters. UNICOM is very pleased to announce that EU-SRS (the European Substances Registration System) is operational at EMA. The