RIM Implementation in times of IDMP - Asphalion Webinar

This video explores the critical intersection of Regulatory Information Management (RIM) system implementation and the ongoing transition to ISO Identification of Medicinal Products (IDMP) standards. The speaker details the current uncertainties surrounding IDMP, the phased rollout of EMA's SPOR project (including PMS and the DADI web form), and the profound impact these changes have on the pharmaceutical industry. A central theme is how RIM systems serve as essential tools to navigate IDMP compliance, emphasizing the need for digitalization, robust data governance, and strategic data migration during implementation.

Key Takeaways:

• IDMP as a Digitalization Catalyst: ISO IDMP is presented not merely as a regulatory requirement but as a significant driver for comprehensive digitalization and the establishment of strong data governance frameworks within pharmaceutical companies, necessitating standardized and interoperable data.
• RIM Systems are Core for IDMP Compliance: Regulatory Information Management (RIM) systems are highlighted as indispensable for IDMP compliance, facilitating efficient data collection, organization, and communication. Future RIM systems are expected to directly support data submission to EMA's PMS via fire messages, evolving beyond current xEVMPD processes.
• Data Quality and Governance are Foundational: Successful IDMP compliance and RIM implementation are contingent upon high-quality, harmonized data. Companies must prioritize data cleaning, enrichment, and mapping, integrating IDMP requirements from the initial planning stages of any RIM project.
• Navigating Phased IDMP Rollout Complexity: The EMA's phased implementation of IDMP through the DADI web form (starting with Centrally Authorized Products (CAPs), then Nationally Authorized Products (NAPs)) introduces a complex transitional period. Organizations must plan to manage the coexistence of legacy and new systems and processes effectively.
• Strategic Implementation is Crucial: Regardless of company size or portfolio, a well-defined strategy for IDMP compliance and RIM implementation is vital. This involves a thorough assessment of existing data structures, internal processes, technological capabilities, and future expectations to select the most compatible RIM system and implementation approach.