Community of expertise: The role of Dose Forms in the generation of a global Pharmaceutical Product Identifier (PhPID)

Online Event - URL on Registration

Defining characteristics for dose forms, which meet global needs, is a challenge addressed by EDQM and several stakeholders. This webinar will present the views regarding the “global” aspect of dose form definition: in the regulatory space, in the clinical space, in the domain of adverse event monitoring and what efforts EDQM is deploying to meet […]

UNICOM Day at the IHE Europe Connectathon

montreux , Switzerland

The purpose is to familiarize the UNICOM partners and impacted stakeholders with the well-established and robust IHE testing and certification process, including the tooling available to support these processes. The session will have a special focus on the interactions between Regulation and Authorization authorities - industry (representing Development and Production) and medicinal product dictionary providers […]

UNICOM Community of Expertise: SUBSTANCE and EU-SRS

Webinar via Zoom

The 4th of November a Community of Expertise will be held for which you have been invited. The presenters will be Annet Rozema, Mirjam Keulen & Marcel Hoefnagel from CBG, The Netherlands, UNICOM WP 2. Substances have been the topic of the UNICOM Community of Expertise before and this is not a surprise as substances […]

Community of Expertise: IDMP data : from source to final use

Webinar via Zoom

Description: Referring to the landscape of medicinal product data – from “research and development” to “utilisation and outcome assessments”- the vision is that the essential IDMP identifiers remain used and unchanged along that life cycle. This Community of Expertise (CoE) will provide opportunity : for industry to present their perspective and needs, with large international […]

UNICOM Community of Expertise: Global alignment on substances based on the ISO IDMP and the SRS software

Virtual

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, the role of a global substance ID in the medicinal product lifecycle and the challenges faced. The presentation will also demonstrate how a new resource […]

UNICOM Community of Expertise: Putting UNICOM ressources to the test

Virtual

Across the UNICOM project we have been actively developing a number of standards-based resources, including FHIR Implementation Guides, a Product Lifecycle Management portal (with EMA), an IDMP database, a substitution service for cross-border dispensation, and a few patient facing apps with dedicated API’s to access medicinal product information (with Gravitate Health). These resources are meant […]

UNICOM Community of Expertise: Standards for Safe Medication Data

The UNICOM project has been working to improve patient safety and enable better healthcare for all, through the implementation of IDMP related standards and terminologies within a variety of processes and systems across the landscape of medicinal product development, use and evaluation. Our key focus has been on the provision of safe medication data, using […]