Wednesday - November 1, 2023 - 12:10

Risk minimisation measures and how to implement and the impact on PBRER and Signal management

Wednesday - November 1, 2023 - 14:15

Fireside Chat - Ensuring Effective REMS Implementation: Strategies for Compliance and Inspection Readiness

• What is the role of Quality and Compliance discipline within REMS development/operations?
• What are some of the biggest challenges regarding stakeholders’ compliance?
• How do you ensure internal organization REMS compliance 
• What are some recommendations when submitting compliance and audit plan with your REMS submission?
• Does inspection readiness help to demonstrate ensuring REMS compliance? Is there a mechanism in place for REMS specific inspection readiness?
• How do you ensure the inspection readiness oversight of REMS administrators, contracted vendors, PMO etc.