Module 12 Presentations

PLM eAF as part of TOM (pre conditions)

• A structured application form (eAF) solution that is compatible with the data model described in IDMP international standards and able to manage FHIR messages for data submissions into PMS data repository; • A shared EU data governance framework aimed at defining roles and responsibilities for data maintenance and management including aspects related to data validation processes in the context of the regulatory assessment; • Capabilities of issuing exchanging and maintaining medicinal product identifiers across the EU Regulatory Networks.

Source: EMA’s EU IDMP Implementation Guide Chapter 3: Process for the electronic submission of medicinal products information

The Organisation for Professionals in Regulatory Affairs