Risk Evaluation

MAY 27–28, 2021

Interactive Training to Prepare and Assess Risk Evaluation and Mitigation Strategies (REMS) for Products Requiring Extra Risk Management for Safe and Effective Use

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Quick Overview

Attendee will be provided an overview on the basics of REMS, their different types and properties, and how to create an assessment plan for REMS.

Who Should Attend

This training course is designed for anyone looking for processing of customer complaints, recalls, and field alerts:
  • Quality Assurance
  • Regulatory Affairs
  • Complaint Handling Professionals
  • Service Technicians
  • Design Assurance Teams
  • Process Development Professionals
  • Project Managers
  • Regulatory Professionals
  • CAPA Teams
  • Product Safety

Key Learning Objectives

  • Purpose of REMS; specifically, Elements to Assure Safe Use (ETASU)
  • Different types of REMS elements and objectives
  • Review of current Regulatory guidance/blogs regarding REMS
  • Creation of an assessment plan for REMS
  • Consideration of all aspects from a people, process, and systems perspective