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Tuesday, June 29 • 2:00pm - 3:00pm
#239 L: Quality by Design for Clinical Trials: A Hands-On, Multi-Stakeholder Workshop

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Component Type: Workshop
Level: Intermediate
CE: ACPE 1.00 Application UAN: 0286-0000-21-575-L04-P; CME 1.00; IACET 1.00; RN 1.00

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 Objectives

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.

Chair

Zachary Hallinan

Speaker

Facilitator
Ansalan Stewart, PhD

Facilitator
Dagmar Goertz

Facilitator
Helen Howitt


Speakers
ZH

Zachary Hallinan

Senior Project Manager, Clinical Trials Transformation Initiative (CTTI), United States
As a senior project manager for the Clinical Trials Transformation Initiative (CTTI), Zachary Hallinan manages the development and implementation of CTTI projects in collaboration with team leaders and multi-stakeholder project teams. His portfolio includes Patient Group Engagement... Read More →
avatar for Dagmar Goertz

Dagmar Goertz

Director Organizational Excellence, Janssen-Cilag GmbH, Germany
Dagmar holds the role of Director Organizational Excellence in BioResearch Quality & Compliance (BRQC) at Johnson & Johnson. She joined the healthcare industry in 1988 and gained several years of experience in pre-clinical/clinical research at Grünenthal. Before she joined Pfizer... Read More →
avatar for Helen Howitt

Helen Howitt

Senior Director, Process Quality Management, Syneos Health, United Kingdom
Helen Howitt is an experienced Quality Management professional with over 25 years' industry experience. She has a particular interest in Quality by Design principles and risk based approaches to clinical trial execution.
avatar for Ansalan Stewart

Ansalan Stewart

Health Scientist Policy Analyst, OMP, CDER, FDA, United States

Tuesday June 29, 2021 2:00pm - 3:00pm EDT
TBD Virtual Event Horsham, PA 19044
  08: RD Quality-Compliance, Workshop |   02: ClinTrials -ClinOps, Workshop