Regulatory & Compliance
IDMP Compliance and Ontology-Driven Data Structures
IDMP — the ISO standard for Identification of Medicinal Products — requires pharmaceutical data to be expressed using standardised reference data in precisely defined data structures. Organisations that have invested in ontology-driven data governance find IDMP compliance far more achievable than those that have not.
Regulatory & Compliance
Semantic Models for ICH M11 Clinical Study Protocol Standards
ICH M11 defines a harmonised structure for clinical study protocols and introduces the concept of a digital protocol that can be machine-processed by regulatory agencies. Implementing M11 with a semantic data model transforms protocol authoring from a document process into a knowledge management process.
Regulatory & Compliance
Mapping Internal Terminologies to MedDRA and SNOMED CT
Most pharmaceutical organisations have accumulated internal clinical terminologies — project-specific coding systems, legacy database value sets, local disease classifications — that must be mapped to MedDRA or SNOMED CT for regulatory reporting and cross-system interoperability. Building defensible, maintainable mappings requires a systematic methodology.
Regulatory & Compliance
Regulatory Submission Intelligence: Mining Precedents from Prior Approvals
Prior regulatory approvals — public assessment reports, review memoranda, approval letters — contain a vast and largely untapped knowledge base about what evidence regulators consider sufficient for specific approval decisions. Structured mining of this precedent knowledge transforms regulatory strategy from experience-dependent art to evidence-informed science.
Regulatory & Compliance
Data Governance for Ontology-Managed Pharmaceutical Assets
An ontology is only as valuable as the governance processes that keep it accurate, current, and trusted. Data governance for ontology-managed knowledge assets requires specific organisational structures, change control processes, and quality metrics that differ from conventional data governance frameworks.