Risk Evaluation and Mitigation Strategies (REMS) what you need to know in order to comply with FDA’s new requirements

June 1, 2009

What you need to know in order to comply with FDA’s new requirements :Risk Evaluation and Mitigation Strategies (REMS)

FDA compliance training will be valuable who are involved in the development of REMS and who are planning a submission and need to understand what might be required by FDA and how to comply and for those who have Risk Management Plans.

Learn here –

  • What is a REMS(Risk evaluation and mitigation strategies)?
  • What products are currently required to have a REMS(Risk evaluation and mitigation strategies)?
  • Where to start when writing a REMS(Risk evaluation and mitigation strategies)?
  • What department need to be involved in the preparation of a REMS(Risk evaluation and mitigation strategies)?
  • Without a REMS(Risk evaluation and mitigation strategies) guidance document …What format is FDA currently requiiring,?

Source: ComplianceOnline