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Quality by Design for Clinical Trials: A Hands-On, Multi-Stakeholder Workshop
Session Chair(s)
Zachary Hallinan
Senior Project Manager
Clinical Trials Transformation Initiative (CTTI), United States
The modernization of ICH E8 emphasizes a Quality by Design (QbD) approach to trial design. In this workshop, apply new resources to capture key design decisions, define organizational strategy for implementation, and identify metrics for tracking progress.
Learning Objective : Apply new resources supporting key elements of quality by design (QbD), including capturing trial-specific factors that are critical to successful completion and safety, and proactively addressing risks of ‘errors that matter’; Design an organizational strategy for implementing QbD, including application of a maturity model and metrics framework to evaluate current state, identify priorities, and track progress.
Speaker(s)
Facilitator
Ansalan Stewart, PhD
FDA, United States
Health Scientist Policy Analyst, OMP, CDER
Facilitator
Dagmar Goertz
Pfizer Pharma Gmbh, Germany
Director GCP Risk Management Lead
Facilitator
Helen Howitt
Syneos Health, United Kingdom
Senior Director, Process Quality Management
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