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EU Telematics beyond Cost and Timelines
Session Chair(s)
Klaus Menges, DrMed
Project Manager
BfArM, Germany
Master Data as accessible from the Article 57 database seems to offer new opportunities to save workload and improve data quality. However, multiple factors are involved such as IDMP iterations, controlled vocabulary, systems and platforms, fees, and public guidelines and will require a critical path analysis for dependencies, conditions and adaptations before realising benefits.
Speaker(s)
Implementation of an IDMP Compliant Databases and Maintaining Up-To-Date Regulatory Data Challenges - The European Medicines Regulatory Network
Francisco Penaranda Fernandez
European Medicines Agency, Netherlands
Head of Department, Business Data and Analytics
What Can Industry Stop Doing after Implementation of ISO-IDMP? A Regulatory View
Ulrike Vollmer, DrSc
Bayer AG, Germany
Global Regulatory Submission Manager, Sponsor Administrator CTIS
What Can Regulators Expect to Benefit after Implementation of ISO-IDMP? A Regulatory View
Klaus Menges, DrMed
BfArM, Germany
Project Manager
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