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.
In light of the global COVID-19 pandemic, 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 and Ravi Krishnamurthy 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, SVP of Life Sciences V. “Bala” Balasubramanian will lead three sessions:
- Session 9, Track 2: Enabling Regulatory Strategy through Automation and Analytics on Wednesday, February 10 at 11:00 a.m. to 11:15 p.m. (with SVP Ravi Krishnamurthy on An Architectural Framework for R&D Analytics and Impact Analysis).
Objectives include:- Identify practical ideas for enabling Regulatory Strategy and Regulatory Intelligence activities through emerging technology and analytics tools
- Transform data into intelligence through analytics capabilities
- Understand the use of an analytics platform for regulatory and R&D
- Session 10, Track 2: Introducing DIA RIM Reference Model 1.0 on Wednesday, February 10 at 11:45 a.m. to 1:00 p.m.
Objectives include:- Introduce the RIM Reference Model Version 1.0 with underlying information constructs and data elements/relationships
- Validate RIM reference model with potential implementations
- Identify implementation opportunities and risks
- On Demand 3 Track 2: Using Intelligent Automation and Advanced Technology to Enhance Regulatory Performance on Wednesday, February 10 at 4:15 p.m. to 5:15 p.m.
Objectives include:- Describe the various types of intelligent automation (IA) technologies and how they can solve key regulatory problem areas or use cases
- Establish a comprehensive data reuse strategy
- Discuss regulatory IA usage and provide an industry viewpoint on IA solutions and how to validate them
Learn more about the DIA RSIDM 2021 Conference.
Learn more about Orion’s Life Sciences expertise and ReALM®.