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Designing quality into clinical trials: ICH E8 (R1)
The impact of updated regulatory guidance on up front clinical trial planning has become more complex. We will discuss an overview of ICH E8 (R1) including the proactive planning of clinical studies using Quality by Design and Critical to Quality Factors Assessments. The aim is to ensure trial operational feasibility, subject safety, and quality data for submissions from a multistakeholder lens. This involves input from critical stake holders and proactively defining risks during the protocol design phase and throughout the product lifecycle. We will also address mitigation and management of potential risks using a quality management approach.