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DIA 2021 Global Annual Meeting


Quality by Design for Clinical Trials: A Hands-On, Multi-Stakeholder Workshop

Session Chair(s)

Zachary  Hallinan

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)

Ansalan  Stewart, PhD

Facilitator

Ansalan Stewart, PhD

  • Health Scientist Policy Analyst, OMP, CDER
  • FDA, United States
Dagmar  Goertz

Facilitator

Dagmar Goertz

  • Director Organizational Excellence
  • Janssen-Cilag GmbH, Germany
Helen  Howitt

Facilitator

Helen Howitt

  • Senior Director, Process Quality Management
  • Syneos Health, United Kingdom