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CO-LOCATED EVENTS

Speaker

Alice Borghi

Digital Solutions Manager, Emvo | European Medicines Verification Organisation

Alice Borghi is Manager of the Digital Solutions team at the European Medicines Verification Organisation (EMVO) where she supports the team in overseeing the quality of the data uploaded in the European Medicines Verification Systems (EMVS) and in analysing the EMVS alerts. Prior to this role, in her 4-years’ experience within EMVO, she covered the role of Manager of the Quality Assurance team first and of Manager of the IT Projects afterwards. Alice holds a PhD in Biotechnology and Biochemistry and before joining EMVO, she worked in the Quality Assurance/Site Compliance department of different pharmaceutical companies.

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Session

Compliance with the EU Falsified Medicines Directive — Leveraging the EU Hub

Case Study

Tuesday, September 23

09:25 am - 09:50 am

Live in Berlin

Less Details

After 6 years from the implementation of the EU Falsified Medicines Directive in Europe, more than 300.000 product codes have been uploaded in EU Hub. Despite the positive evolution of the system, some challenges still need to be addressed to improve data quality and reduce false positive alerts, which are key factors to ensure full compliance, increase trust in the system and strengthening the EMVS. This session will take you through the journey of achieving compliance with the Falsified Medicines Directive via the EU Hub. You will learn more about:

  • The journey of a Pharmaceutical Company from onboarding to the EU Hub via the OBP Portal to data upload in the EU Hub (Product Master Data and Product Pack Data) and alert handling via the Alert Management System.
  • Use cases on actions to support Pharmaceutical Companies in ensuring compliance in the PMD.
  • Use cases on how non-compliance in the PPD creates alerts.
Presentation

Company

Emvo | European Medicines Verification Organisation

The European Medicines Verification Organisation “The European Medicines Verification Organisation (EMVO) is the guarantee of patient security in Europe.” The European Medicines Verification Organisation (EMVO) has taken responsibility for advancing the formation of the European Medicines Verification System (EMVS). The EMVS is in accordance with the EU’s Falsified Medicines Directive (FMD) and the Delegated Regulation (DR). It ensures the implementation of a functioning, secure, interoperable and cost effective system across Europe. The infiltration of falsified medicines in the European supply chain is a major and continuous threat for the patient health and security. Because patient health and safety is of the utmost importance to the pharmaceutical industry, a comprehensive strategy at European Level is required. Therefore the European Medicines Verification Organisation (EMVO) was created as a joint initiative of EU stakeholders, representing manufacturers (Medicines for Europe, EFPIA, Affordable Medicines Europe), wholesalers (GIRP) and community pharmacists (PGEU).
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Colocated with
Pharma Maintenance Europe 2025 is part of the Smart Manufacturing & Industry 4.0 Event Series. You can find more events here.
Date
September 22 – 23, 2025
Location
Maritim proArte Hotel
Friedrichstraße 151, Dorotheenstraße 65
10117 Berlin
Phone
+49 (0)30 52 10 70 3 0
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