Jump to content

Quality by Design

Course Information

The modernisation of ICH E8 emphasises a Quality by Design (QbD) approach to trial design. The Clinical Trials Transformation Initiative has built and is currently expanding a suite of resources for learning about, teaching others, and applying QbD principles in clinical trials.  These include evidence-based recommendations for QbD, a principles document, case studies, and other resources that will give sponsors and other stakeholders the tools and confidence they need to effectively implement QbD at their organisation. In this workshop, participants will:

  • Learn about QbD principles and review available QbD resources,
  • Hear and discuss case studies highlighting diverse models of implementation and lessons learned
  • Apply the principles and resources to a hypothetical trial, and
  • Join a discussion on implementation models and best practices that may support their organisations in implementing QbD.

Course Tutors

Tutors will be:

Ann Meeker-O'Connell
Vice President, Vertex




Course Programme


Course Material

Following requests from attendees of previous RQA events we are pleased to offer course material in PDF format for delegates attending this course. 

The advantages of this include

  • Ability for delegates to keep material on a mobile device
  • Ability to review material at any time pre and post course
  • Environmental benefits – less paper being used per course

The material will be emailed in advance of the course and RQA will not be providing any printed copies of the course notes during the training itself. Delegates wishing to have a hard copy of the notes should print these in advance to bring with them. Alternatively delegates are welcome to bring along their own portable devices to view the material during the training sessions.


Back to list