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30-Jan-2019 - 30-Jan-2019

An Introduction to Risk Evaluation & Mitigation Strategies (REMS)

  • Location:
    • Venue to be confirmed

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 USAimplementation 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.

Please note that we are also running:

Book together and save

This meeting runs back-to-back with Writing Risk Management Plans (RMPs) on 4 July 2018 and also Producing and Maintaining the Pharmacovigilance System Master File (PSMF) on 5 July 2018. There is a further £100/€140 discount off each course when booked together.

To find out more please call Customer Services on +44 (0)20 7749 4730 or e-mail info@management-forum.co.uk