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Quality by Design REMOTE LEARNING

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.

Participants will hear answers to questions such as:

  • Is the trial I've designed answering the question I intended?
  • How can I better streamline my trial?

Course Tutors

Tutors will be comprised from the list below:

Ann Meeker-O'Connell
Vice President, Vertex

(click here to view Ann's presentation at the 3rd EU QA Conference on this topic)

Sameera Ibrahim 
Bristol Myers Squibb

 

Course Programme (timings TBC)

12:00 - 17:00 GMT

  Introductions and Scope of the Course
  LEARN - Understand background to inception of Quality by Design
  UNDERSTAND - Principles of Quality by Design
  Break
  DISCUSS - Case Studies
  Break
  PRACTISE - Workshop on application of principles
  FEEDBACK
  Question Time and Summary 
  Close of Course

Course Material

This course will be run completely online. You will receive an email with a link to our online system, which will house your licensed course materials and access to the remote event. 

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
  • Access to an online course group to enhance networking

You will need a stable internet connection, a microphone and a webcam. 

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