Agenda: Introduction to Fimea Medicinal product database demo Lessons learned Priority actions expected from EMA Speakers: Joonas Tuominen (Fimea) Anu Ollikainen (Fimea) Markus Mäkelä (Fimea) Juha Jokimäki (Solita Finland Oy)
REGISTER NOW FOR THIS EVENT Advanced FHIR training: How to track changes on a medicinal product? UNICOM is happy to invite all of you to the 4th NCA FHIR training on October 13 10-12 CEST. This webinar focus topic is: “How to track changes on a medicinal product?” "Provenance" in the Variation FHIR message: Free text […]
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UNICOM is happy to announce a new series of IDMP implementation related training and knowledge transfer webinars in 2023. Considering the recent progress with EMA eAF we believe that it is important that all European NCAs acquire without delay a better understanding of the FHIR standard and its relevance in relationship to a wide IDMP […]
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 – EMA Implementation Guide v2.0 The course of IDMP implementation in Europe is strongly influenced by European Medicines Agency's (EMA) guidance. On Monday 22 February, EMA released version 2.0 of its Implementation guide (EU IG v2.0). This is a very important milestone for UNICOM and our communities, which will be presented and discussed at our […]
The UNICOM monthly, interactive Community of Expertise webinar sessions address issues related to the identification of medicinal products (IDMP) in regulatory and clinical contexts. On Friday, 4 December, UNICOM holds the fifth CoE webinar addressing how IDMP is supporting COVID-19 immunization: A number of new vaccines will arrive on the market with the purpose to […]
The UNICOM monthly, interactive Community of Expertise webinar sessions address issues related to the identification of medicinal products (IDMP) in regulatory and clinical contexts. On Thursday November, 12th UNICOM holds the fourth CoE webinar addressing: How substances/products have been selected for piloting, and How this is moving to support use of IDMP data across multiple domains […]
In February 2020, the European Commission unveiled its data strategy, culminating in the creation of an infrastructure and governance for the free flow of personal data under the control of individuals. Following this announcement, Digital New Deal has published Personal Data Sharing: Governance as a Game Changer. Governance is needed to enable the switch from […]
