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 2012 and the implementation guides, which are currently under development 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 master data management initiatives.
This short course is aimed at providing stakeholders with a foundational knowledge of IDMP to support practical implementation within their organizations. More specifically, the course will demonstrate applied strategies and technologies used for the implementation, address practical issues within the regulatory landscape, and show relationships with established processes such as eCTD, XEVMPD, and SPL.
*Short Courses are not included in the forum registration and require a separate fee.
At the conclusion of this short course, participants should be able to:
- Provide an introduction and overview on ISO IDMP
- Review the ongoing international standardization work on IDMP
- Recognize the main features of the five IDMP standards and corresponding technical specifications
- Prepare all relevant stakeholders for the implementation of the new IDMP standards with respect to their business requirements and RIM systems
- Define the relationships and dependencies between IDMP and existing processes like eCTD, XEVMPD, and SPL
- Share best practices for information management
- Review state-of-the-art technologies to support information management