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An Introduction to Risk Evaluation & Mitigation Strategies (REMS)


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Who should attend?

This course is applicable for those working in the area of product risk assessment or wanting to learn more about the USA implementation of ICH E2E risk approaches for medicines. This includes pharmacovigilance personnel working in safety review and risk assessments, QA, clinical personnel and EU QP PVs.

Details

INTRODUCTION

The course will provide insight into the FDA thinking of which products qualify for a Risk Evaluation and Mitigation Strategies (REMS), the different categories of REMS, their introduction and maintenance and the reporting assessments on the REMS. The course will also briefly look at the approaches between the EU and USA for the same product under an RMP or REMs programme.

Topics to be covered will include:

  • The background to REMS
  • What products qualify for REMS?
  • Understand the different categories of REMS
  • Discuss their introduction, maintenance and reporting assessments
  • Contrast the approach between the US and FDA for a RMP or REMS programme

WHO SHOULD ATTEND?

This course is applicable for those working in the area of product risk assessment or wanting to learn more about the USA implementation of ICH E2E risk approaches for medicines. This includes pharmacovigilance personnel working in safety review and risk assessments, QA, clinical personnel and EU QP PVs.

Prices

GBP EUR USD Standard 699 979 1090 Excluding VAT @ 20.00%

Contact

Leigh White
info@management-forum.co.uk

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