Module 12 2019

The State of Data and Standards Regulatory World View

SPOR Iterative approach to IDMP Falsified Medicines

Structured Product Monograph – SPL Format Utilizing IDMP Data Elements Regulatory Enrolment Process – SPL Format aligning with IDMP Data Elements (future state) eCTD v3.2.2. v4

Directive (FMD) Cross border e- Prescriptions Article 81-EU CT Regulation SPOR/IDMP

PQ/CMC ICSR CDISC Activities Medical Device UDI eCTD v4 *IDMP – Federal Notice*

Medical Device (UDI) ICSR FMD IDMP/SPOR