Module 12 Presentations

Digital Transformation requires Data Standards

There is a growing need for standardization (and alignment across the standards)

✓ Growing amounts of data & information → more complex decision making ✓ Data harmonization and digital automation is key to reduce the burden ✓ Several concurrent standardization initiatives exist, but further alignment required

Struct. Quality Data in Module 3 – ICH M4Q - SPQS & PQ/CMC

(Regulated) product information – ISO IDMP “flavors”

Clinical Trial Regulation – CTIS

EU Individual Case Safety Report ICSR – E2B(R3)

Structured clinical trial protocol – CeSHarP / ICH M11

HL7 FHIR data exchange standard

Global drug dictionaries/IDs WHO-UMC

SDTM standard for data collection of risk assessment data

Structured Labelling ePI, XML PM, SPL

The Organisation for Professionals in Regulatory Affairs