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Unlocking Innovation: Implementing Future-Focused Risk-Based Quality Management Quality Briefs - A Cross-Functional Challenge
Session Chair(s)
Paula Walker, MA
Global Head of Risk Based Quality Management
Roche Products Ltd., United Kingdom
Join us as we delve into the cutting-edge realm of risk-based quality management (RBQM) and learn how quality briefs revolutionize compliance reporting both internally and for externally for regulators. Discover how quality briefs offer proactive transparency at the time of filing, incorporating ICH E8/E6(R3) expectations, and focusing on highest risk critical to quality (CtQ) areas. Gain insights from real-world case studies of multi-company implementations, and uncover strategies to collaborate across functions for swift product delivery while maintaining stringent quality standards. Explore how quality briefs drive a paradigm shift in quality management, moving from gatekeeping at the end of the process to proactive involvement from the start, in line with ICH E6 R3 and E8 R1 quality by design principles. Learn how to craft the GCP compliance story of your product's development, with each CtQ factor assessed for compliance status at filing, supported by evidence and data analytics insights. Dive into the 'How' of implementation, with practical guidance for companies keen on adopting this transformative approach, including updates on Health Authority engagement.
Learning Objective : Critique the methodology behind implementing the outcomes-based approach of quality briefs in risk-based quality management (RBQM), illustrating how it demonstrates the compliance status of critical to quality (CtQ) factors; Design effective cross-functional communication strategies within a company to facilitate the implementation of changes required for adopting quality briefs, emphasizing collaboration; Identify the key challenges and successes derived from real-world insights.
Speaker(s)
Panelist
Cheryl Grandinetti, PharmD
FDA, United States
Clinical Pharmacologist, OSI, OC, CDER
Panelist
Jennifer Emerson, PhD, MPH, RN, PMP
Boehringer Ingelheim, Germany
Head Quality Analytics & Risk Management
Panelist
Jamie Bridges, MPH
Merck Sharp & Dohme LLC , United States
Executive Director, Clinical Quality Assurance
Panelist
Alissa Mun, MS
FDA, United States
Health Scientist Policy Analyst, OMP, CDER
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