Short Course Registration: 7:30AM-12:00PM
In December 2010, new pharmacovigilance legislation was adopted by the European Parliament and European Council to require the use of common standards, formats and terminologies in the EU for the identification and exchange of information on medicines. Specific reference is made to the ISO Identification of Medicinal Product (IDMP) standards that were finalized in 2017 and the corresponding technical specifications developed with international standards development organizations (i.e., ISO and HL7). IDMP is a significant undertaking, but it also presents opportunities in terms of how Regulators and Industry manage and share data, both internally and externally, to support global product lifecycle data management.
This Short Course is aimed at providing stakeholders with a foundational knowledge of IDMP to support practical implementation within their organizations. More specifically, the tutorial will address issues within the regulatory landscape and demonstrate applied strategies for the implementation of the ISO IDMP to support global medicinal product identification. Topics to be addressed include a background of the IDMP standards and legislation, and an overview of the overall structure, content, and technical requirements of IDMP. More importantly, this tutorial will present practical examples and offer a demonstration of applied IDMP concepts to directly address regulatory initiatives and requirements. This session is applicable to entry and intermediate level stakeholders.
- Overview of the IDMP: Structure, Format, and Exchange in Application
- Status of IDMP in Europe
- Recognize the main features of the IDMP standards and corresponding technical specifications
- Understand the content and message exchange requirements for the submission of medicinal product information by relevant stakeholders
- Demonstrate applied strategies for the implementation of ISO IDMP beyond compliance (true benefit across the value chain within an organization)
- Understand and apply IDMP concepts regulatory and other business needs
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