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EMA Implements E8(R1)

E8(R1) builds on the "quality by design" principles previously set out, and include focusing on critical to quality factors to ensure the rights, safety and wellbeing of study participants. Importantly from an Risk-Based Quality Management (RBQM) perspective, it also talks about the management of risks to those critical to quality factors using a risk-proportionate approach.

Key features of the approach also include:

  • Establishing a culture that supports open dialogue

  • Focusing on activities essential to the study

  • Engaging stakeholders in study design

In the section on "Critical to quality factors in operational practice", the guidance talks about conducting feasibility assessments on the study design and implementation elements that could impact the study from an operational perspective.

This obviously links to E6(R2) and the up-coming E6(R3). We've discussed in the past how E8(R1) and E6(R3) create a 'quality continuum', with one supporting the other to increase the quality of clinical trials.

If you'd like to know more about practical steps to E8(R1) implementation, and the links to E6(R3), please join our webinar on 12th May. Click here to register.


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