Course Description
ICH E8 (R1) is intended to identify and modernize the present conduct of clinical research, including clinical trial design, planning, management, and conduct. In clinical research, quality assurance activities of retrospective document checking, monitoring, auditing, or inspection are essential, and there has been an overreliance on these tasks versus relying on designing quality into clinical studies during development and throughout clinical research. This web seminar covers the importance of designing quality into clinical trials with a focus on Quality by Design (QbD) of clinical studies, critical factors to quality, essential identification of quality factors, establishing a culture that supports critical thinking and open dialogue regarding proactive quality versus reliance on tools/checklists, and stakeholder engagement.
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Learning Objectives
Who Should Attend
Instructor
Andy Lawton
Hold this course at your company! For more information, contact Naila Ganatra at +1 215.413.2471.