IRISS TG meeting
Unicom developments around IDMP from a NCA (AGES) perspective by George Neuwirther IDMP Ontology by Heiner Oberkampf and Raphael Sergent EU-SRS by Annet Rozema
Key messages from the fifth transatlantic meeting
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 […]
UNICOM Community of Expertise: Global alignment on substances based on the ISO IDMP and the SRS software
A report on progress and challenges from the Global IDMP Working Group (GIDWG), about substances. The presentation will give an overview of the GIDWG work on global alignment of substances, […]
A vast majority of European National Competent Authorities engaged in 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 […]
EMA Product Management Service (PMS) progress webinar
Public webinar intended for business, developers and technical audiences working for industry and national competent authorities that are interested in learning more about the Product Management Service (PMS) development progress and […]
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 […]