Clinical Risk Management Conference
September 12-14, 2022 | San Diego, CA + Virtual
Create an interactive hands-on learning environment specifically designed for emerging companies developing their clinical quality risk management approach. Identify the critical elements of an effective clinical quality approach to understand how to build a culture of quality from the ground up and lay a strong foundation for compliance and a confident state of inspection readiness, all utilizing limited resources. Join your peers in a candid sharing of experiences as we learn how to build and initiate effective clinical quality risk management strategies for emerging companies. Learn more ›
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AQC Members:
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Join WCG Avoca for the following sessions:
September 13 – Main Day One
9:00am PT – ICH E6 R2 AND R3
Breakdown the Elements of ICH E6 (R2) and ICH E6 (R3) That Relate to Clinical Risk Management
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- Outline the elements of ICH E6 (R2 and R3) that pertain to clinical risk management
- Identify the overriding principles of Quality by Design
- Define critical to quality factors and evaluate their purpose
- Embrace a quality culture
- Evaluate what is required and what is recommended and how regulatory agencies have responded
- Are companies currently being inspected to ensure compliance with these elements?
- Outline the elements of ICH E6 (R2 and R3) that pertain to clinical risk management
Presenter: Michelle Webb, Vice President, WCG Avoca Quality Consortium
9:30am PT – EXPERT PANEL: TRANSLATE REGULATIONS INTO PRACTICE
Understand How the Principles of ICH E6 R2 and R3 Are Being Applied to Clinical Risk Management
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- Hear case study examples of how companies are applying risk management principles from R2 and R3
- Understand what a quality culture looks like at a small company and learned practices for building and maintaining it
- Outline how risk-based approaches are being executed and how to prioritize implementation
- Share level of inspection readiness and what ongoing actions are being taken to prepare
Moderator: Michelle Webb, Vice President, WCG Avoca Quality Consortium
3:30pm PT – ROUNDTABLE DISCUSSIONS
#4: Quality Culture Assessment: Share Strategies for Assessing the Health of your Company’s Culture of Quality
Facilitators: Michelle Webb, Vice President, WCG Avoca Quality Consortium
Caryn Laermer, Head, Member Engagement, WCG Avoca
September 14 – Main Day Two
11:15am PT – EXPERT PANEL: ESCALATION PLANS AND CLINICAL CAPAs
Discuss Real-Life Examples of What Should and Should Not Happen with Issue Escalation and Corrective and Preventive Actions (CAPAs)
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- Share measurable approaches for mitigation and remediation when a risk is realized
- Learn best practices from experiences where the communication of issues did not occur in a timely or effective manner
- Outline the critical elements of a clinical CAPA and how to oversee the proper execution and check effectiveness
Presenter: Karen Harvey, Senior Director, WCG Avoca Quality Consortium
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