The Drug Information Association (DIA) recently hosted its Regulatory Submissions, Information, and Document Management (RSIDM) Forum in North Bethesda, MD. Here are a few of our takeaways from the event.
At the DIA’s annual RSIDM Forum, attendees from across the life sciences industry came together to discuss evolving data standards and requirements and to share insights on regulatory information management (RIM) approaches.
The Forum included four main tracks:
- Regulatory Informatics Business
- Regulatory Informatics Technology
- Trial Master File (TMF) Inspection Readiness and Electronic Document Management
- Electronic Regulatory Submissions
After some virtual and hybrid years, it was great to be in person at the event and even better to see topics previously shared in the theoretical put into practice with demonstrated value. Here are three takeaways from the Daelight team:
- NLP and ML are taking center stage
- SCA solutions are optimizing document creation processes
- IDMP is on its way … again
1. NLP and ML Are Taking Center Stage
The use of Natural Language Processing (NLP) and Machine Learning (ML) in life sciences is moving out of the “concept” stage. There are now life sciences companies (and health authorities!) that are putting NLP and ML into practice, but they are only sometimes succeeding on the first try. When they do succeed, the results are impactful.
Powerful solutions that leverage NLP, ML and context-sensitive searching are speeding access to the precise data needed.
2. SCA Solutions Are Optimizing Document Creation Processes
Structured Content Authoring (SCA) has also moved from concept to practice. Successful implementations are targeted at specific document types, and feedback is that it’s best to start with a targeted use case and take an agile approach.
Effective change management is critical to transitioning authors from document authoring to component authoring. The journey to implement is long, but the value-add for large organizations with high verbatim content reuse is high.
SCA optimizes document creation and ensures accurate and consistent content is shared across critical documents. Use cases include:
- Labeling (CCDS, USPI, EU SmPC, Local PIs)
- Pharmacovigilance agreements
- Protocols
- Clinical study reports
- Investigator brochures
- Non-clinical study reports
Some companies are taking this a step further by leveraging SCA and NLP analytics to achieve automation of content authoring.
3. IDMP Is On Its Way … Again
The Identification of Medicinal Products (IDMP) is the set of International Organization for Standardization (ISO) standards that aims to facilitate the unique identification of medicinal products in the context of pharmacovigilance and the safety of medications throughout the world.
Going beyond the standards, a major theme of RSIDM 2023 was how companies prepare to meet this new level of data curation. And how, as an industry, can companies avoid “standardizing” by creating their own unique language to align with the IDMP terminologies, reducing the benefits IDMP could provide?
Efforts within the RIM Reference Model and IDMP Ontology projects are looking to reduce semantic incongruency by providing software-agnostic logical data models and principles, bridging the gap between people, processes, and systems.
Strong reference data management and governance processes will be vital to successful Regulatory systems. Constantly engaging different groups in a cross-functional manner throughout implementations will ensure the entire business stays informed and adheres to new processes and data models.
Conclusion
DIA’s RSIDM Forum 2023 offered insightful presentations that highlighted exciting trends that are happening now and in the near future. As the Forum revealed, the landscape of Regulatory is changing – are you ready for the new challenges and opportunities?
Daelight Solutions is a life sciences IT company that is focused on providing Regulatory consulting that helps streamline submissions and ensure compliance. If you need help in this space, contact us.