Module 12 Presentations

26/01/2024

FDA Support for US Data Requirements

The Organisation for Professionals in Regulatory Affairs

10

47

HL7 Electronic Labeling Standard: Structured Product Labeling

• Utilizes eXtensible Markup Language (XML)  Machine readable tags to improve search functionality across systems • Usability across multiple database platforms  Interoperability  Compatibility  Portability • Supports electronic health information initiatives  Electronic health records/electronic prescribing

The Organisation for Professionals in Regulatory Affairs

48

24