Module 12 Presentations

EMA’s way to implement IDMP: SPOR

EMA Master Data databases:

S ubstance M anagement S ervices

11238: Substance 11616: Medicinal Product 11615: Pharmaceutical MP N/A 11239: Dosage form Routes of administration 11340: Units of measures

P roduct M anagement S ervices

O rganisation M anagement S ervices

R eferentials M anagement S ervices

The Organisation for Professionals in Regulatory Affairs

Feb 1st, 2024 – TOPRA Module 12