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Monday, September 27 • 8:30am - 12:00pm
WORKSHOP B: Proactive Risk Management at Emerging Companies

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Implement R2 Compliant Risk Management Approaches With Limited Resources
  • Outline the critical factors of ICH E6 R2 that changed the risk management approach
  • Examine how risk management has been modernized in response to ICH E6 R2
  • Leverage risk management to predict GCP risk and the impact on monitoring and auditing planning
  • Describe an approach for identifying important questions to ask about a protocol that can identify risk

Speakers
avatar for Michele Weitz

Michele Weitz

Senior Director, Clinical Standards and Innovation, CLOVIS ONCOLOGY
A pragmatist on a mission to make clinical trial regulatory requirements meaningful and accessible to a tough crowd, Michele has worked as both an employee and consultant at pharmaceutical companies of all sizes—from 23 to 111,000 employees, in many therapeutic areas and around... Read More →


Monday September 27, 2021 8:30am - 12:00pm EDT