Gens and Associates - 2020 World Class RIM - Structured Data Submissions

This video provides an in-depth exploration of Section six, "Structured Data Submissions," from the 2020 World Class RIM (Regulatory Information Management) survey conducted by Gens and Associates. The speaker, Kelly NAT, guides viewers through nine questions designed to assess approaches, costs, and resource requirements related to both existing and upcoming structured data submission mandates within the pharmaceutical and life sciences industries. The primary objective is to gather comprehensive data on how organizations are currently managing these critical regulatory submissions and their preparedness for future requirements, particularly those from the European Medicines Agency (EMA).

The discussion begins by addressing current structured data submission requirements, focusing on the capabilities and solutions companies have in place. Question 33 probes the status of existing capabilities, listing various submission types and the diverse solutions employed, such as manual population of internal tools, direct electronic submission from internal systems, reliance on external vendors, or direct entry into Health Authority portals. The survey allows for multiple selections per row, acknowledging that companies often utilize hybrid approaches. Following this, Question 34 specifically targets the handling of xevMPD third acknowledgment records received from the EMA after quality reviews of submitted xevMPD data, offering several options for how these acknowledgments are processed.

The latter half of the section shifts focus to future and upcoming structured data submission requirements. Questions 35 through 37 delve into initiatives and strategies companies are employing to prepare for these evolving mandates. The survey lists common strategies observed across the industry but also invites participants to share internally developed approaches, recognizing the unique challenges and solutions companies might devise. The video then highlights specific major initiatives: the EU IDMP SPOR initiative (Question 38) and UDEMED (Question 39). For these, the survey asks participants to estimate the number of months required to achieve full readiness for compliant submissions to the EMA, providing a range of timeframes for selection. The final questions, 40 and 41, address the anticipated costs associated with preparing for IDMP SPOR and UDEMED, respectively. These questions differentiate between costs already incurred and additional expected spend, specifying cost categories such as software, external consultants, external service providers, and data remediation/migration, while explicitly excluding internal resource costs to ensure consistent data comparison. Participants are also asked to indicate their level of confidence in future cost estimates.

Key Takeaways:

• Criticality of Structured Data Submissions: The video underscores the ongoing and increasing importance of structured data submissions for regulatory compliance in the pharmaceutical and life sciences sectors, particularly with mandates from bodies like the EMA.
• Diverse Management Approaches: Companies employ a variety of methods for managing existing structured data submissions, ranging from manual processes and internal tools to leveraging external vendors or direct interaction with Health Authority portals. Many organizations utilize a combination of these approaches.
• Specific Regulatory Focus on xevMPD: The survey specifically investigates how companies handle xevMPD third acknowledgment records from the EMA, highlighting the granular detail required for managing post-submission regulatory feedback.
• Proactive Preparation for Future Mandates: A significant portion of the survey is dedicated to understanding how companies are strategically preparing for upcoming structured data submission requirements, such as the EU IDMP SPOR initiative and UDEMED.
• Strategic Planning for Compliance: Companies are encouraged to articulate their specific initiatives and strategies for future compliance, including internally developed approaches, indicating a need for tailored solutions beyond generic industry practices.
• Estimating Readiness Timeframes: Organizations are asked to estimate the time (in months) required to achieve full readiness for compliant submissions to the EMA for major initiatives like IDMP SPOR and UDEMED, providing insight into project timelines and resource allocation.
• Comprehensive Cost Estimation: The survey requires a detailed breakdown of anticipated costs for compliance, including software, external consultants, contractors, external service providers, and data remediation/migration. This provides a holistic view of financial investment.
• Exclusion of Internal Resource Costs: To ensure data consistency across survey responses, companies are specifically instructed not to include internal resource costs in their budget estimates, allowing for clearer benchmarking of external expenditures.
• Tracking Current vs. Future Spend: The survey distinguishes between dollars already spent and additional dollars expected to be spent, offering a phased view of financial commitment towards regulatory readiness.
• Confidence in Cost Estimates: Participants are asked to provide a level of confidence (high, medium, low) for their future cost estimates, acknowledging the inherent uncertainty in projecting future expenditures for complex regulatory projects.
• Value of Aggregated Data: The survey emphasizes that all collected data is blinded, encouraging companies to share sensitive budget and strategy information to contribute to valuable industry-wide benchmarks and insights.
• Evolving Regulatory Landscape: The continuous introduction of new sections and questions in the World Class RIM survey reflects the dynamic and evolving nature of regulatory information management and compliance requirements.

Key Concepts:

• Structured Data Submissions: Data submitted to regulatory authorities in a predefined, machine-readable format to ensure consistency and facilitate processing.
• xevMPD: Extended EudraVigilance Medicinal Product Dictionary, a database of medicinal product data in the European Union, managed by the EMA.
• EMA (European Medicines Agency): The agency responsible for the scientific evaluation, supervision, and safety monitoring of medicines in the European Union.
• EU IDMP SPOR Initiative: The European Union's implementation of ISO Identification of Medicinal Products (IDMP) standards, focusing on Substances, Products, Organizations, and Referentials (SPOR) data.
• UDEMED: The European Database on Medical Devices, a central database developed by the European Commission to enhance market surveillance and transparency for medical devices.
• Health Authority Portal: Online platforms provided by regulatory bodies (like the EMA) for direct submission and management of regulatory data.
• Data Remediation and Migration: Processes involved in correcting errors or inconsistencies in data and transferring data from one system or format to another, often a significant part of preparing for new regulatory requirements.