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Virtual Event

Jun 14, 2020 9:00 AM - Jun 18, 2020 5:00 PM

(Eastern Standard Time)

Fort Washington, PA 19034

DIA 2020 Global Annual Meeting

Implementing Quality by Design for Clinical Trials: New Tools, Case Studies, and Multi-Stakeholder Discussion

Session Chair(s)

Ann  Meeker-O'Connell, MS

Ann Meeker-O'Connell, MS

Director, Office of Clinical Policy, Office of Clinical Policy and Programs, OC

FDA, United States

The modernization of ICH E8 emphasizes a Quality by Design (QbD) approach to trial design. In this forum, discover new QbD resources for sponsors and all stakeholders, and join a discussion on implementation models and best practices.

Learning Objective : Compare diverse models of QbD implementation at the trial and company/organization levels, and identify best practices; Discuss benefits and best practices for multi-stakeholder engagement in the QbD process, including patients, sites, CROs, and regulators; Explain how to apply freely-available resources for evaluating current state of QbD adoption, developing an implementation and tracking progress.

Speaker(s)

Sabrina  Comic-Savic, MD, MPH

Orion-4: A Case Study of QbD Application at the Trial Level

Sabrina Comic-Savic, MD, MPH

Novartis, United States

Vice President, Quality Assurance, Clinical Project Oversight

Kerstin  Koenig, PhD, MSc

CTTI QbD Maturity Model

Kerstin Koenig, PhD, MSc

GSK, United States

Vice President, Global Quality Assurance

Fergus  Sweeney, PhD

Panelist

Fergus Sweeney, PhD

European Medicines Agency, Netherlands

Head of Clinical Studies and Manufacturing Task Force

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