Managing regulatory information can be challenging, especially now that it has a larger impact on operational efficiency, data quality, and ultimately on a company’s ability to meet patients’ needs. As requirements, technologies, data sources, and regulations evolve, effective Regulatory Information Management (RIM) is critical.

The need for operational efficiency across regulatory has evolved at a faster rate than ever before, as companies scramble to bring treatments and vaccines to patients. At DIA’s Regulatory Submissions, Information, and Document Management (RSIDM) forum, Life Sciences leaders V. “Bala” Balasubramanian will join industry and regulatory stakeholders working across the regulatory information landscape to examine and improve data standards, requirements and approaches for RIM.

This forum provides multiple opportunities for networking, knowledge sharing, and education for both business and technology-focused attendees. As one of the program committee members, V. “Bala” Balasubramanian will lead four sessions:

  • BONUS Session: RIM Reference Model 1.0 – Validation Workshop (In-Person Exclusive) on Monday, February 14 at 9:00 a.m. to 12:00 p.m.
  • Objectives include:
    • A recap of the RIM Reference Model structure and content along with feedback received from the industry.
    • A live demonstration of the model to show how “objects and data elements” relate to regulatory activities and regulatory objectives with a validation exercise using CMC Variation.
    • Encourage industry and vendor participation to further validate the work done so far and uncover any opportunities for the use of intelligent automation in support of the CMC Variation process.
    • Formally release Version 1.0 of the Reference Model for industry/vendor use.
    • Update on progress made around AI use cases and call for industry participation.
  • Welcoming Remarks and Presentation of the Excellence in Service Award on Monday, February 14 at 1:00 p.m. to 1:25 p.m.
    Objectives include:
    • Provide an overview of the three tracks and themes for this year’s forum. 
    • Recognize a DIA member who has consistently provided outstanding service as a volunteer within the RSIDM community, and who has contributed to the advancement of DIA’s mission.
  • Session 6 Track 2:Driving Data Integration, Data Governance, and Data Quality Monitoring Through Data Standards on Tuesday, February 15 at 11:15 a.m. to 12:30 p.m.
    Objectives include:
    • Focus on several aspects related to data unification, data integration, data governance, and data quality monitoring through emerging data standards such as IDMP, PQCMC, and structured data submissions.
    • Explore how organizations can get ready to meet IDMP requirements through the assessment of data sources and data quality through the use of intelligent data mapping and reporting techniques.
  • Session 10 Track 2: Cross-industry Collaboration and Cross-functional Integration of Data on Wednesday, February 16 at 10:30 a.m. to 11:45 a.m.
    Objectives include:
    • Collaboration across the industry with the creation of a platform for Health Authorities to collaboratively review submissions.
    • Use of Reference Data Management (RDM) as a powerful approach to integrate data without the challenges that arise from extraction, transformation, and loading (ETL) of data.
    • Integration of regulatory data with manufacturing data for better impact analysis and decision making.

Find our team at Booth 306 at the conference in Bethesda North Marriott Hotel and Conference Center to showcase our RIM capabilities. Book a meeting to talk to our experts.

Find out about our technology solution for Regulatory Affairs Lifecycle Management ReALM®.

Watch the video of Regulatory Intelligence & Submissions Planning modules

Learn more about Orion’s Life Sciences expertise.

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