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 REMSdocument.
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.

Sample Solution

Ascent of the Argentine Ants

With the appearance of Argentina insect, Linepithema humile was presented. This is a fast substitution of insect species all through the world because of (1) visit assaults, obsession and executing of nearby ants, and (2) hereditary homogeneity, (3) huge rivalry With serious rejection, quick situating and quick selection (4) without utilizing common ants and parasitoid honey bees. L. Initially delivered in Argentina, humor spread quickly everywhere throughout the world with shockingly quick speed.

By all accounts, the Argentine insect resembles a customary subterranean insect. In any case, they might be the main species we can colonize on three mainlands other than us. In Europe, South America and Asia, each of the three supergroups of Argentina ants are made out of ants with the equivalent hereditary qualities, and are basically a similar subterranean insect populace. The topographical degree of these settlements is enormous to such an extent that the social structure of these states likewise bewildered science for some time. Ali perceives their siblings when their siblings assemble, however is forceful against different types of ants. Likewise, the present ants hereditary code has not changed much for a great many years. This is unusual as their common ecological animals for the most part develop quickly and Argentine ants are definitely not.

In contrast to most different ants in California, Argentine ants are normally shallow and their homes reach out down the outside of the dirt. Be that as it may, under dry conditions, they gather further in the dirt. Besides, despite the fact that the settlements of Argentine ants are not isolated, they structure a huge “super province” along with a few sovereign. At the point when a recently mated sovereign is scattered in another state, they are joined by laborers as opposed to going out like most different species. In the structure, family ants eat sugar, syrup, nectar, juice, fat and meat. The long method of thousands of ants can extend from the home to the food source, causing significant worry in building an occupant. Open air ants are interested by sweet dew, delicate scales, whitefly and ticks. This fluid waste contains sugar and different supplements. At the point when ants use them for honeydew, scales and ticks frequently show up, as ants can shield scales and ticks from characteristic foes.

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