DIA 2025 Global Annual Meeting

Component Type: Session
Level: Intermediate

Internal solutions for translation between regulatory frameworks to assure right use of control vocabularies to exchange data as structured components of submissions to Health Authorities, CMOs, CROs. Controlled vocabularies, ontologies. Presentation of AstraZeneca core data model to enable translation and mapping for data integration. Define use case for data exchange (with data products TLFs for CMC, iterative submissions by piloting the future representing data). vocabularies and business rules to enable data exchange. How everything connects to each Semantic Model Patient Centric vs. Study Centric for reuse scenarios - Amgen will present PQI Standards to build a regulatory filing. Map different regulatory standards frameworks to enable translation between frameworks (e.g., EMA and FDA) into messaging standards like HL7 FHIR. Reference Global Standard benefits (ICH M4Q, Q12, SPQS, IDMP and GSRS). A call for a solution – Interoperability as a Plan – open sources and sharing the standards – What would Dom do? Exchanging structured data everyone is using the same viewer in the Amgen use case. Regulatory Authorities and Industry must collaborate on solutions for development and application of standards to data. Platforms like Accumulus[2] to present the CMC data and translate from one set of standards to another for access for information. Finally we will discuss Digitial Equity and Transparency - one set of data, exposed in a variable output to HAs, supporting critical operations from source whilst maintaining the Digitial nature of data.

Learning Objectives

Analyze how regulatory digital data from divergent sources must meet varying ICH and Regulatory Authority standards; Identify gaps in applying external regulatory standards to internal industry data; Examine specific examples of gaps, such as enhanced granularity and differing regulatory frameworks (e.g., IDMP, XEVMPD, GSRS).

Chair

David Sidney Ross, MBA, MSc, PMP, RAC

Speaker

Panelist
Mathew Woodwark

Panelist
Dominique Lagrave, PharmD

Panelist
Rita Algorri, PhD, MS