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SCOPE Summit Europe & Clinical Trial Innovation Summit 2020 Virtual Event

INTERACTIVE BREAKOUT DISCUSSION GROUPS
Date: November 10, 2020

Breakout 7: Implementation of Clinical Development Risk Management
Moderators:
Linda Sullivan, Executive Director, WCG-Metrics Champion Consortium LLC
Jonathan Rowe, PhD, Associate Principal, ZS Associates
Keith Dorricott, Ambassador, Metrics Champion Consortium
Dagmar Goertz, Director, External Engagement & Business Insights, BioResearch Quality & Compliance, Janssen

  • Is RBM delivering?
  • What is the role of proactively establishing QTLs
  • Any good predictive models?

 

TRACK: ICH E8 REGULATORY GUIDELINES AND RBQM STRATEGY
Date: November 11, 2020

Presentation: How Can Cost of Quality Help Us Implement Quality by Design (ICH E8 R1)?
Keith Dorricott, Ambassador, Metrics Champion Consortium

Panel: Overcoming Challenges of Advancing Risk Based Monitoring and Quality by Design
Panel Moderator: Asmaa Mrabti, Study Risks and RBM Expert, Trial Operations, Sanofi
Panelists:
Keith Dorricott, Ambassador, Metrics Champion Consortium
Marion Wolfs, Head, Senior Director, Risk Management & Central Monitoring, Janssen Pharmaceutical Companies of Johnson & Johnson

 

TRACK: RISK MANAGEMENT AND VENDOR OVERSIGHT: METRICS AND KPIS
Date: November 11, 2020

Presentation: Critical Data and Processes: How ICHE6(R2) Is Changing Vendor Management and the Data Sponsors Are Reviewing during Clinical Studies
Linda Sullivan, MBA, Executive Director, WCG-Metrics Champion Consortium
 
Panel: Risk Management and Vendor Oversight: Metrics and KPIs
Panel Moderator: Andy Lawton, Director & Consultant, Risk Based Approach Ltd.
Panelists:
Marina Malikova, PhD, Executive Director, Surgical Translational Research: Operations and Compliance, Boston University School of Medicine
Linda Sullivan, MBA, Executive Director, WCG-Metrics Champion Consortium

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