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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.
Kathleen Wisemandle
COE & Founder
Aspire to Grow, Clinical Operations Strategic Consulting and Executive Coaching
Kathleen Wisemandle is the CEO and Founder of Aspire to Grow, Clinical Operations Strategic Consulting and Executive Coaching. With over 30 years in the biotechnology and pharma industry, she has built and led global teams to strategically plan for IND through NDA for multiple therapeutic areas (non-oncology and oncology) across all phases. She held leadership positions within Takeda, Astellas, AbbVie and Seagen.
She currently provides fractional clinical trial strategic consulting services to small start-up biotechnology companies working toward optimizing operational strategies and building Critical to Quality (CtQ) and Risk Mitigation Plans as well as Executive Coaching for Pharma/Biotechnology industry professionals.
She earned her BS in Biochemistry from Michigan State University, and she earned her MS in Organizational Change and Learning from Northwestern University in 2020. She completed certifications in Designing for Organizational Efficiency in 2019, and Executive Coaching in 2022 from Northwestern University.