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Monday, June 26 • 4:15pm - 5:15pm
One Year On: How Quality Briefs are Transforming the Approach to Quality and Driving Innovation to Serve Patients

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Component Type: Session
Level: Advanced

This session will include a focused discussion on industry/ health authority collaboration over 2022-2023 on transforming the standard approach to quality: enabling innovation by mitigating risks using quality briefs to build trust and confidence, with outcomes-based transparency.

Learning Objectives

Describe how quality briefs can be proactively shared with Health Authorities and adapted depending on the lifecycle stage/ filing approach taken; Discuss Health Authority reflections on the outcome-focused quality briefs based on experience during 2022-23 including links to quality by design principles on risk management and transparency with regulators.

Chair

Paula Walker, MA

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 →

Monday June 26, 2023 4:15pm - 5:15pm CDT
TBD Boston Convention and Exhibition Center 415 Summer Street, Boston, MA 02210 USA
  08: RD Quality-Compliance, Session