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Monday, June 25 • 3:00pm - 4:15pm
#149: A Quality-by-Design Approach to Trial Design and Conduct: Case Studies from the Clinical Trials Transformation Initiative

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Component Type: Session
Level: Intermediate
CE: ACPE 1.25 Application UAN: 0286-0000-18-546-L04-P; CME 1.25; IACET 1.25; RN 1.25

The Clinical Trials Transformation Initiative (CTTI) and the FDA evaluated methods to prospectively build quality into the scientific and operational design of clinical trials (quality by design). Applying the CTTI quality-by-design recommendations and principles permits organizations to prioritize the most critical aspects of a trial’s quality; identify non-essential activities that can be eliminated to streamline trial conduct and oversight; and develop appropriate plans to define, avoid, mitigate, monitor, and address important errors. This session will provide a brief overview of the CTTI project and recommendations and speakers will describe their experience with implementing a quality-by-design approach in clinical trials.

Learning Objectives

Identify recommendations and lessons learned from the CTTI quality by design project; Describe strategies for implementing a quality by design approach to trial design and conduct.

Chair

Annemarie Forrest

Speaker

Case Study: How a Large Pharma Company Integrates QbD into Clinical Development
Julie Dietrich, MS

A Collaborative Approach to Applying QbD in a CV Outcomes Trial: Lessons Learned
Sabrina Comic-Savic


Speakers
SC

Sabrina Comic-Savic

Vice President, Quality Assurance, The Medicines Company
avatar for Julie Dietrich

Julie Dietrich

Director, Clinical Development, Amgen Inc.
Julie Dietrich is a Director in Amgen’s Center for Design & Analysis (CfDA). The CfDA partners with product teams to design optimized clinical programs and implement innovative solutions. Julie also heads the Patient Experience Program for Amgen’s Clinical Technology & Experience... Read More →
JD

Julie Dietrich

Director, Clinical Development, Amgen Inc.
Julie Dietrich is a Director in Amgen’s Center for Design & Analysis (CfDA). The CfDA partners with product teams to design optimized clinical programs and implement innovative solutions. Julie also heads the Patient Experience Program for Amgen’s Clinical Technology & Experience... Read More →
avatar for Annemarie Forrest

Annemarie Forrest

Director of Projects, Clinical Trials Transformation Initiative (CTTI)
Annemarie Forrest is the Director of Projects for CTTI. Ms. Forrest provides senior operational leadership for core activities such as project management, site management, personnel management, financial performance, regulatory compliance, information systems, and process improve... Read More →

Monday June 25, 2018 3:00pm - 4:15pm EDT
Room 205C Boston Convention and Exhibition Center 415 Summer Street, Boston, MA 02210 USA
  08: R and D Quality-Compliance, Session