XEVMPD/SPOR Compliance
Case study
Challenge
To leverage the data in XEVMPD/SPOR for IDMP compliance and maximize usage of the current systems through harmonized business process.
The European Medicines Agency (EMA) is in the process of implementing IDMP standards that specify standardized definitions to identify and describe medicinal products for human use only. Electronic Application Form (eAF), is being replaced while implementing the Product Lifecycle Management Portal and will be consumed by data from XEVMPD/SPOR.
Solution
RXEVMPD/SPOR/RIM data assessment and mapping according to the new IDMP Guidance - performed by a Senior Regulatory Operations specialist. Agile implementation of the E2E process to maintain XEVMPD/SPOR data accurate aligned with RIM System/IDMP Data standards.
ICON’s value add
Our Team of experts in Regulatory Operations have a strong knowledge of business processes and systems, Health Authority requirements and ability to support change management.
Our diversity of expertises within Regulatory Operations allows us to find solutions to streamline business processes.
We can also liaise directly with Local Offices in Country and prevent issues with submission platforms.
Outcome
- Maintain XEVMPD/SPOR Data accurate to align data with RIM system to support and avoid submission delays (DADI)
- Avoid “Annual PV fees” being charged inaccurately to MAH
- Requests/data tracked and can easily be accessed in order to support future inspections/audits
- Leverage compliance with dashboards/metrics and providing regular compliance/metrics reports