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Critical to Quality Assessment Reports 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). Sponsors will weigh in on the challenges and opportunities related to the value of the CAR for their internal stakeholders.
Learning Objective : Understand the internal value proposition of the Critical to Quality Assessment Report and its application throughout the QMS and beyond; Apply different tactics to persuade and engage internal stakeholders on the value and application of the Critical to Quality Assessment Report.
Speaker(s)
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
Representative Invited
Medicines and Healthcare products Regulatory Agency (MHRA), United Kingdom
A Regulator's Perspective on the Value Proposition of the Critical to Quality Assessment Report
Representative Invited
FDA, United States
A Sponsor's Perspective on Engaging Internal Stakeholders on the Critical to Quality Assessment Methodology and its Application Throughout the QMS
Maria Koukounari, MS, MSc
BMS, United Kingdom
Senior Director Therapeutic Area Quality
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