The DIA Regulatory Submissions, Information, and Document Management (RSIDM) conference brought together industry leaders to discuss the evolving landscape of regulatory affairs. As regulatory requirements grow increasingly complex, organizations must adopt new technologies and methodologies to maintain compliance and efficiency.
Here are Daelight Solutions’ five key takeaways from the conference.
Key Takeaways from DIA RSIDM 2025
1. Data Management and Interoperability are Critical for Regulatory Success
In the digital era, effective data management is no longer optional—it is essential. The transition from document-based to data-centric regulatory processes, such as leveraging Fast Healthcare Interoperability Resources (FHIR) for Chemistry, Manufacturing, and Controls (CMC) data, enables more streamlined submissions. Ensuring seamless data flow across global regulatory agencies requires robust tools, including cloud technologies, Master Data Management (MDM), and structured data elements like Universal Unique Identifiers (UUIDs). These solutions enhance efficiency, improve accuracy, and facilitate compliance with emerging global standards such as Identification of Medicinal Products (IDMP).
2. Artificial Intelligence as a Tool for Transformation, Not Replacement
Artificial intelligence (AI) is a powerful enabler in regulatory affairs, but its impact depends on the quality and completeness of the data it processes. Rather than replacing human expertise, AI should be leveraged to enhance decision-making and efficiency. Organizations should focus on upskilling regulatory teams, implementing AI for tasks like document generation, and strategically applying AI across interdisciplinary functions. The key is to integrate AI as an assistive tool that augments human capabilities rather than replaces them.
3. Regulatory and Technology Alignment is Key for Efficiency
4. Global Standardization Efforts and Challenges
Global regulatory agencies are moving towards adopting IDMP standards, but each region follows its own timeline, creating challenges in standardization. Despite these obstacles, there is a growing emphasis on harmonizing product data and improving data quality to support global submissions. Collaborative efforts, such as the Global IDMP Working Group, play a critical role in addressing these standardization challenges. By fostering international cooperation and developing common frameworks, the industry can work toward a more unified regulatory landscape.
5. Upskilling and Organizational Change for Long-Term Success
As regulatory requirements and technologies continue to evolve, both systems and personnel must adapt. Upskilling regulatory teams is essential to ensuring adaptability in a digital-first environment. Organizations must foster a digital culture, invest in continuous learning, and maintain flexibility to incorporate new tools and processes. Embracing digital transformation with the right skillsets and change management strategies will be key to long-term success.
Conclusion
The DIA RSIDM 2025 conference underscored the importance of digital transformation, data interoperability, and regulatory alignment in navigating the future of regulatory affairs. By embracing data-centric approaches, leveraging AI strategically, ensuring regulatory-technology synergy, addressing global standardization challenges, and upskilling teams, organizations can enhance compliance and efficiency in an increasingly complex regulatory environment.