Module 12 Presentations

Inter-dependencies for EMA S/O/R data

EMA’s Substance, Organisation and Referential Master Data used in many projects and submissions today, with even more to come This same S/O/R master data is also reflected in industry’s PMS (IDMP) data

Source: EMA’s SMS, OMS, RMS webinars (Oct 3-5, 2023)

The Organisation for Professionals in Regulatory Affairs

Feb 1st, 2024 – TOPRA Module 12