An Overview of Risk Evaluation & Mitigation Strategies (REMS)

An 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.

Introduction

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

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

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.

Programme

The background to REMS

  • ICH E2E
  • PDUFA III
  • REMS history

The development of REMS

Products qualifying for REMS

Product specific REMS

The REMS audience

  • Identifying the need for a REMS
  • REMs and educational material
  • REMs and healthcare professionals
  • Pharmacy Systems under REMS
  • Practice settings under REMS

REMS and RMPs

  • Clinical Programme Product identified risks
  • Differences in REMS and RMPs
  • Crossover in REMS/RMPs
  • Lifespan of REMS and RMPs

Managing a REMs programme

  • Introduction of a REMS
  • Assessment of the REMS programme
  • Changes and amendments
  • Safety reviews
  • REMs and RMPs

The Impact of REMS

Continuing professional development

This course qualifies for the following CPD programmes:

  • CPD certificate of attendance

Bespoke training

We can customise this course to meet the requirements of your organisation. Contact us to discuss your training requirements.

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