RIM Data and System Assessment to ensure IDMP compliance
Case study
Challenges
The European Medicines Agency (EMA) is in the process of implementing IDMP standards that specify standardised definitions to identify and describe medicinal products for human use only. It entails the replacement of Electronic Application Form (eAF) by XEVMPD/SPOR data during the implementation of the Product Lifecycle Management Portal. Our goal is to leverage the data in XEVMPD/SPOR for IDMP compliance and maximise usage of the current systems through harmonised business processes.
Solutions
RIM System Configuration and Data Assessment is pivotal in regulatory business planning. It also helps in organising product registration process to track and manage all regulatory activities. It supports end-to-end regulatory data management by offering:
- Exhaustive review of the RIM System Configuration.
- Assessment of product data representative of the client’s portfolio gathered from multiple sources (i.e. RIM system, XEVMPD extracts, module 3 and SmPCs).
- Ensure alignment with controlled vocabularies (RMS).
- Review business processes to ensure data completion effectiveness after process details have been fine-tuned and shared with end-users.
ICON’s value add
Our Team of experts in Regulatory Operations have a strong knowledge of business
processes and systems, authorities’ requirements and ability to support change management and make the link with future iterations for IDMP to find better solutions for streamlining the business process.
Outcomes
This System Configuration and Data Assessment tool for IDMP compliance has facilitated sharing of a list of issues with stakeholders like system owners, end-users and IT / Business compliance representatives, helped define priorities with system owners and provided roadmaps for system configuration and data alignment with limited resources at the same time making these services affordable to the clients.
Our services
RIM System Configuration and Data Assessment comes with the following suite of services:
- Operations support in decentralised or hybrid models for data entry.
- XEVMPD/FMD/IDMP data submissions to health authority standards.
- Business administration of RIM operations.
- Quality checks and gap analysis of multiple sources.
- IDMP/SPOR readiness and compliance assessments.
- Data governance to ensure data are current, accurate, compliant, reliable and fit for purpose.
- Strategies for emerging and changing data standards through regulatory intelligence.