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Tuesday, June 16 • 8:00am - 9:00am
#204 L: Implementing Quality by Design for Clinical Trials: New Tools, Case Studies, and Multi-Stakeholder Discussion

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Component Type: Forum
Level: Intermediate
CE: ACPE 1.00 Knowledge UAN: 0286-0000-20-604-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 forum, discover new QbD resources for sponsors and all stakeholders, and join a discussion on implementation models and best practices.

Learning Objectives

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.


Ann Meeker-O'Connell, MS


Orion-4: A Case Study of QbD Application at the Trial Level
Sabrina Comic-Savic, MD, MPH

CTTI QbD Maturity Model
Kerstin Koenig, PhD, MSc

Fergus Sweeney, PhD

avatar for Ann Meeker-O'Connell

Ann Meeker-O'Connell

Vice President, Integrated QMS/OMS, Vertex Pharmaceuticals
Ann Meeker-O’Connell, MS, serves as Vice President, Integrated QMS/OMS at Vertex. Ann has more than twenty years of experience in biomedical research and development in government, academia, and industry settings, including leading the Division of GCP Compliance at the US FDA. She... Read More →
avatar for Fergus Sweeney

Fergus Sweeney

Head of Clinical Studies and Manufacturing Task Force, European Medicines Agency, Netherlands
Fergus Sweeney is Head, Clinical Studies and Manufacturing Taskforce at the European Medicines Agency since March 2020, covering Clinical Studies (Clinical Trial Information System), Biological Health Threats and Vaccine Strategy and supports strategy development in manufacturing... Read More →
avatar for Kerstin Koenig

Kerstin Koenig

Vice President, Research and Development Quality, Bristol-Myers Squibb Company, United States
Kerstin Koenig, PhD is the Head of Research & Development Quality, Bristol Myers Squibb. In this role, she is responsible for the development and strategic oversight of the world-wide quality assurance and quality management activities in the area of Product Development Quality, GLP... Read More →

Sabrina Comic-Savic

Vice President, Quality Assurance, Clinical Project Oversight, The Medicines Company

Tuesday June 16, 2020 8:00am - 9:00am EDT
TBD Virtual Event Horsham, PA 19044
  08: R-D Quality-Compliance, Forum