Module 12 2019

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.

➢ We will come back to this!

The Organisation for Professionals in Regulatory Affairs