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
