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ENCePP Guide on Methodological Standards in Pharmacoepidemiology


11.1. General principles of quality management

Quality in research impacts on regulatory practice, medicines development and public health. Quality is a measure of excellence and quality management includes all the activities that organisations use to direct, control and coordinate quality (International Standards Organization, ISO 9000). Quality management principles as described in ISO Quality management principles are also applicable to pharmacoepidemiological research. The book Total Quality Management-Key Concepts and Case Studies (D.R. Kiran, BSP Books, Elsevier, 2016) deals with the management principles and practices that govern the quality function and presents all the aspects of quality control and management in practice.

The Commission Implementing Regulation (EU) No 520/2012 and the Good pharmacovigilance practices (GVP) Module I provide a framework for the quality management of pharmacovigilance and safety studies of authorised medicinal products. Measurable quality requirements can be achieved by:

  • Quality planning: establishing structures (including validated computerised systems) and planning integrated and consistent processes;

  • Quality assurance and control: monitoring and evaluating how effectively the structures and processes have been established and how effectively the processes are being carried out;

  • Quality improvement: correcting and improving the structures and processes where necessary.

Pharmacoepidemiological research is becoming more complex and may use a large amount of data. In such situation, managing quality implies a risk-based approach. Risk-based quality management is incorporated as Good Clinical Practice expectation in ICH E8 (R1) and addressed in the European Commission’s Risk proportionate approaches in clinical trials, EMA’s Reflection paper on risk-based quality management in clinical trials and the GVP Module III on Pharmacovigilance inspections.

The considerations and recommendations of Chapter 5.1 on the definition and validation of drug exposure, outcomes and covariates are essential aspects that need to be addressed for quality management.



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