Module 12 2019

IDMP, a burden?

• IDMP more work, more effort… why do we want it? o Difficult to ”sell” internally to top management • xEVMPD has been a benefit!

o Change in QPPV details and PSMF location. No variation, direct reporting into the database • Could IDMP actually lead to reduction of effort/waste? • We need IDMP! If we want to optimise processes in Regulatory

Affairs SPOR/IDMP is enabler to realise this! • Build a business case of IDMP implementation

The Organisation for Professionals in Regulatory Affairs