Risk Evaluation and Mitigation Strategy
- Pick a pharmaceutical or biologic that is approved in the EU or US that does not presently have a REMS Risk Evaluation and Mitigation Strategy.
- Try to choose one that has had previous safety issues as evidenced by either communications from Regulatory Authorities or SAE’s (Serious Adverse Event) reported by healthcare facilities or patients.
- Prepare a REMS for the product that you choose following the FDA guidance document, “Format and Content of a REMS Document, dated October 2017. https://www.fda.gov/media/77846/download
- Each REMS should contain a either a mocked-up patient enrollment form or a prescriber enrollment form.
- Make sure that you include at least one REMS element (i.e., Medication Guide, patient package inserts or communication plan).
- The REMS element will be separate from the REMS. Either do it as a separate document that is appended to the REMS or start it separated by a page or section break of your REMS
Note: if the drug or biologic you choose has a medication guide then you cannot provide the medication guide as your one REMS element.
You will have to choose another REMS element to provide. The REMS elements should be created by you.
Times New Roman, 12 font
Cite your references.
REMS document that includes:
- Include either a mocked up patient or prescriber enrollment form
- Include one REMS element (i.e., Medication Guide, patient package inset or communication plan)