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Wednesday, June 19 • 8:00am - 9:00am
#308: Unlocking Innovation: Implementing Future-Focused Risk-Based Quality Management Quality Briefs - A Cross-Functional Challenge

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Component Type: Forum
Level: Intermediate
CE: ACPE 1.00 Application UAN: 0286-0000-24-629-L04-P; CME 1.00; RN 1.00

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 Objectives

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.

Chair

Paula Walker, MA

Speaker

Panelist
Cheryl Grandinetti, PharmD

Panelist
Jennifer Emerson, PhD, MPH, RN, PMP

Panelist
Jamie Bridges, MPH

Panelist
Alissa Mun


Speakers
avatar for Paula Walker

Paula Walker

Global Head of Risk Based Quality Management, Roche Products Ltd., United Kingdom
Paula is the Global Head of RBQM at Roche, having started with the company with a Quality Policy focus. Formerly Head of Compliance (GCP/PV/GLP) at the MHRA and Acting Head of Inspectorate, having started in 2009 as a GCP Inspector; spending 13.5 years at the Regulator. Paula has... Read More →
avatar for Jamie Bridges

Jamie Bridges

Executive Director, Clinical Quality Assurance, Merck Sharp & Dohme LLC , United States
Jamie Bridges has 26 years of pharmaceutical experience. She began her career at Pfizer and spent the past 25 years with Merck based out of West Point, PA. Her career has included leadership roles in Data Management, Epidemiology, Operational Excellence and most recently Clinical... Read More →
avatar for Jennifer Emerson

Jennifer Emerson

Head Quality Analytics & Risk Management, Boehringer Ingelheim, Germany
Clinical research professional with more than 20 years' experience in Quality Management, Project Management, Monitoring & Pharmacovigilance. PhD in Public Health - Epidemiology, Project Management Professional (PMP) Certified, ISO 9001:2015 certified Auditor. Current role: Head of... Read More →
avatar for Cheryl Grandinetti

Cheryl Grandinetti

Clinical Pharmacologist, OSI, OC, CDER, FDA, United States
Dr. Grandinetti is a reviewer in the Good Clinical Practice Assessment Branch of the Division of Clinical Compliance Evaluation /Office of Scientific Investigations in CDER/FDA. She provides regulatory and scientific oversight for CDER-assigned bioresearch monitoring activities and... Read More →
AM

Alissa Mun

Health Scientist Policy Analyst, OMP, CDER, FDA, United States

Wednesday June 19, 2024 8:00am - 9:00am PDT
Room 8 San Diego Convention Center 111 W Harbor Drive, San Diego, CA 92101 USA
  08: RD Quality-Compliance, Forum