This course gives you an introduction to :

• REMS principles, content, implementation, reporting and assessment
• When a REMS is required
• Differences between REMS and RMP

It provides examples of REMS that have been implemented to reduce patients’ risk from their medications.

At the end of the course, you will :

• Understand how REMS are useful tools to reduce risk to patients from their medication

• Know when FDA requires REMS

• Know when REMS are tailored to the specific risk and can include one or more specified elements

• Know when sponsors must report periodically to FDA on REMS effectiveness