Life Sciences and Pharmaceuticals: Terminology and Acronyms
Description
Covers the language of pharma: clinical, regulatory, business, and IT acronyms, standard reference codes, classification systems, and documentation jargon essential for interfacing with business and end users.
Learning Objectives
Learners will master terminology (ICD, CPT, MedDRA, NDC, EHR, API, GMP, QMS, REMS, etc.), understand data standards (HL7, CDISC, eCTD), and apply correct usage in IT product configuration and communication.
Topics (10)
Definitions, regulatory context, example usage in IT workflows.
How product codes support supply chain, traceability, patient safety in IT systems.
HL7 and FHIR for messaging, data integration in pharma research/health IT.
Process and system linkage for quality/compliance.
Importance in AE case capture, coding, and global reporting.
Value communication, market segmentation, payer workflows.
Role in clinical trial datasets, safety reporting, data analysis tools.
Electronic reporting for safety, labeling, compliance (E2B, IDMP, XEVMPD).
Digital infrastructures and data governance for global regulatory submissions.
Example usage and value in IT project documentation.