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:
Tutors will be:
Vice President, Vertex
Following requests from attendees of previous RQA events we are pleased to offer course material in PDF format for delegates attending this 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.