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:
Participants will hear answers to questions such as:
Tutors will be comprised from the list below:
Vice President, Vertex
(click here to view Ann's presentation at the 3rd EU QA Conference on this topic)
Bristol Myers Squibb
"The presenters were enthusiastic, knowledgeable and kept the pace from start to finish. I was able to build on existing knowledge and also gained new ideas. I enjoyed the workshop as I don't get opportunity to meet and chat with such a wide range of QA people in my day-to-day work. The slides and course handouts were ideal and I will be referring to them again in future."
"I now have a very good understanding of QbD. Having a complex protocol as an example was a good learning experience."
|Introductions and Scope of the Course|
|LEARN - Understand background to inception of Quality by Design|
|UNDERSTAND - Principles of Quality by Design|
|DISCUSS - Case Studies|
|PRACTISE - Workshop on application of principles|
|Question Time and Summary|
|Close of Course|
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.
Please note this course will run in UK timezone.
You will need a stable internet connection, a microphone and a webcam.