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Risk Evaluation and Mitigation Strategy (REMS)


Eu2P Short Course: Risk Evaluation and Mitigation Strategy (REMS)

OBJECTIVES

This course gives you an introduction to :

  • REMS principles, content, implementation, reporting and assessment
  • When a REMS is required
  • Differences between REMS and RMP

It provides examples of REMS that have been implemented to reduce patients’ risk from their medications.

REMS, principles, content, implementation, reporting, assessment, RMP, FDA

 

LEARNING OUTCOMES

At the end of the course, you will :

  • Understand how REMS are useful tools to reduce risk to patients from their medication

  • Know when FDA requires REMS

  • Know when REMS are tailored to the specific risk and can include one or more specified elements

  • Know when sponsors must report periodically to FDA on REMS effectiveness

 

135 minutes
Online based learning
English language
Certificate of Achievement
225 € / $260
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AUTHORS

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Dr. John Price

Pharmaceutical physician consultant, patient safety, pharmacovigilance and regulatory affairs
Independent

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Nasop Experts Group

ISoP's North American chapter




COMPANIES OFFER

Short courses can be included in a training package for your team!


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