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An Introduction to Risk Evaluation & Mitigation Strategies (REMS)




London, UK


06 Jul 2018

Reference No: M1803276 - MAF

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Event Description

Course Outline:

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

When & Where?

6 July 2018

Cavendish Hotel
81 Jermyn St,
St. James's


GBP 699*
EUR 979*
USD 1,090*

*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.

GBP & EUR Prices exclude VAT

Applicant Requirements
  • 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
  • Pharmacovigilance personnel working in safety review and risk assessments, QA, clinical personnel and EU OP PV's
Reference No: M1803276 - MAF
For over 30 years Management Forum has been an internationally renowned independent training company which organises professional conferences, seminars and in-house courses for the Life Science and Intellectual Property sectors.


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