Zina Sadeq

Director, Regional PV & Alliance Management - Amicus Therapeutics

Zina Sadeq


  • 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.

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