Project Resources

UNICOM - general information

Year	Title	Description	Download
2020	UNICOM Fact Sheet	Short introduction to UNICOM Action lines, objectives	PDF File
2020	BADI Bulgarian Drug Regulatory Affairs e-Congress (June 2020)	The slides present the objectives pursued by UNICOM to a EU regulatory authority and Bulgarian key stakeholders not directly active within the UNICOM consortium.	PDF File
2020	HL7 FHIR / Unicom Joint Meeting (May 2020)	Karl Stroetmann presents the objectives purused by UNICOM and its implementation challenges including the synergies to be found with SDOs such as HL7/FIHR.	PDF File
2020	Commentary published in the review Vaccine	Commentary published in the open source journal Vaccine on December 2 2020. It details the urgent actions needed to ensure we can track and trace the global use of COVID-19 vaccines.	PDF File

Year	Title	Description	Download
2020	Working Document: Gap Analysis of Existing and Need for New Standards and Profiles	Work package 1 focuses on IDMP-related standards and terminologies; its first deliverable is concerned with gaps in existing standards and profiles, and the arising need for adapted and new ones.	PDF File
2020	Medicinal Product, Marketing Authorization, Pharmaceutical Product and Package Medicinal Product: Briefing Note by Jean Gonzague Fontaine (GSK)	The slides provide an overview of the relations between • MPID• PhPID• MA• PCID (and then, DCID) and explain the possible hierarchy between these IDs.	PDF File
2020	IDMP related standards and terminologies applied to pharmacovigilance: Presentation Individual Case Safety Report. Briefing note by Anja van Haren	The slides briefly describe the expected benefits of IDMP implementation for the pharmacoviguilance domain.	PDF File
2021	Working Document: Requirements for a new ISO logical model [platform independent]	The document raises requirements for the development of a new IDMP logical model, to serve as a reference to implementers and developers of specific data models. It presents what is meant by a “logical model”, provides several references which document logical models and their conceptual, standardised framework.	PDF File

Year	Title	Description	Download
2020	Working Document: Endorsed Implementation Plan for Substance Management	This deliverable presents the Implementation Plan for Substance Management, i.e. the roadmap for the EU Substance Reference System (EU-SRS) implementation.	Soon available
2020	WP2-Cleaned Substances Report	The EU SRS excel file is a searchable database for stakeholders interested in using this information	xlsx File
2020	WP2-Data cleansing Manual	The Data Cleansing Manual Substance Validation Group (SVG) has developed this “Guidance on EU Substance Data Cleansing” as part of the EU-SRS project. This is an External version- living document.	PDF File