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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 ›

 

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

    • 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?

 

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

    • 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

 

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)

    • 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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