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Critical to Quality Assessment Report from Inception to Operationalization: How to Engage Internal Stakeholders
Session Chair(s)
Kiernan Trevett, MSc
Quality Policy Lead
Genentech, A Member of the Roche Group, United States
There is an opportunity to inspire and engage internal stakeholders on the value proposition of the Critical to Quality Assessment Report (CAR) (formerly termed 'Quality Brief'). Sponsors will weigh in on the challenges and opportunities related to the value of the CAR for their internal stakeholders.
Learning Objective : Recognize the internal value proposition of the Critical to Quality Assessment Report (formerly termed 'Quality Brief') and its application throughout the QMS and beyond; Discuss ways to apply different tactics to persuade and engage internal stakeholders on the value and application of the Critical to Quality Assessment Report.
Speaker(s)
Critical to Quality Assessment Report: Overview and Value Proposition
Kiernan Trevett, MSc
Genentech, A Member of the Roche Group, United States
Quality Policy Lead
A Regulator's Perspective on the Value Proposition of the Critical to Quality Assessment Report
Cheryl Grandinetti, PharmD
FDA, United States
Associate Director for Clinical Policy, CDER/OC/OSI/DCCE
A Sponsor's Perspective on Engaging Internal Stakeholders on the Critical to Quality Assessment Methodology and its Application Throughout the QMS
Jennifer Emerson, PhD, MPH, RN, PMP
Boehringer Ingelheim, Germany
Head Quality Analytics & Risk Management
A Regulator's Perspective on the Value Proposition of the Critical to Quality Assessment Report
Mandy Kaur Budwal-Jagait, MSc
Medicines and Healthcare products Regulatory Agency (MHRA), United Kingdom
Head of GCP
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