Module 12 Presentations

Data Governance and Quality Systems

• Data governance policies have become a regulatory expectation as one of the core quality system policies. • It has been stated by the Medicines and Healthcare products Regulatory Agency (MHRA), European Medicines Agency (EMA), World Health Organization (WHO), Pharmaceutical Inspection Cooperation Scheme (PIC/S), and the Australian government’s Therapeutic Goods Administration (TGA) that a data governance system should be an integral part of the pharmaceutical quality system.

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The Organisation for Professionals in Regulatory Affairs