Clinical Quality Oversight has ended
Back To Schedule
Monday, September 27 • 8:30am - 12:00pm
WORKSHOP B: Proactive Risk Management at Emerging Companies

Log in to save this to your schedule, view media, leave feedback and see who's attending!

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

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