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P113: Achieving IDMP Compliance with Digital Regulatory Information Management and SPOR Data Synchronization Solutions

Poster Presenter

Joan Cheung

Senior Consultant
NNIT
United States

Objectives

This case study is to outline the use of digital solutions in Regulatory Information Management System (RIMS) and SPOR Data Synchronization to improve an international pharmaceutical company's readiness for the upcoming European Medicines Agency's Identification of Medicinal Product regulations.

Method

Digital solutions implementation and deliverables were completed remotely with system workshops and business process meetings, with Regional Regulatory Affairs, Global Regulatory Operations, and Chemistry, Manufacturing, and Controls departments starting in 2023 with systems Go-Live in 2024.

Results

The project involved multiple workstreams aimed to address pressing issues that came with complying with upcoming EMA regulations. The focus of all workstreams were two-fold to address the following: 1. The RIMS update to ensure compliance with the IDMP Data Specification, and ability to generate IDMP Compliant output (i.e. eAF Form) 2. The SPOR data synchronization solution would import/export the correct values as needed between RIMS and EMA SPOR databases. The project methodology involved: • Extensive discussions were held to review the IDMP requirements and implications in terms of data entry and data gathering for the RIMS configuration. • Data analysis was used to understand the equivalent data values between all systems. Deliverables included a glossary of IDMP terminology, and an interactive database that mapped specific RIMS data fields to IDMP requirements. • A gap analysis to better understand the current process and what governance documents would be affected by the new regulations. In-scope documents were analyzed and updated per feedback from stakeholders and new business process. The team also aligned on business naming conventions for free text fields in RIMS to allow better data matching between the RIMS and SPOR data synchronization solution. • System validation documents were created in parallel with the business governance documents to ensure alignment. • A Role-based, Hands-on Training Course for RIM was developed to acclimate users to the new requirements, processes, and procedures for IDMP compliance. Materials developed included a Master User Guide, governance documents, and Quick Reference Guides. For the EU countries, a 4.5 day, In-Person session was delivered. For the non-EU Countries, 2-day Virtual Training sessions were delivered. These discussions and insights were part of a positive feedback loop to ensure users had all the information needed to populate all systems.

Conclusion

As the regulatory requirements set out by health authorities evolve to utilize data to enhance patient safety and traceability, pharmaceutical companies should consider improving infrastructure and current practices to future proof the company. Benefits of this project were seen across multiple areas including regulatory compliance, regulatory operations, and data governance: • Regulatory Risk Mitigation • Efficient Cross functional Product Data Communication • Timely Product Submission Approvals • Improved Response Time to Regulatory Inquiries • Improved Ability for Product Data Compliance with Agency Initiatives such as PQ-CMC, E2B(R3) FDA regional variation, and EMVO • Support for Future Improvements such as Structured Content Authoring • Improved Data Governance Procedures for data completeness, correctness, and up-to-date As additional digital solutions enter the market to meet upcoming regulations, pharmaceutical companies must complete a thorough evaluation of their current human resources and infrastructure to ensure the best product-company fit. Additional resources and time may be needed to ensure data governance from data entry to output are compliant with the everchanging regulatory requirements, especially in terms of user education and familiarity with both the regulations and digital solutions.