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.
Political factor is all about how and to what extend a government intervenes in the economy or a particular industry and how it affects business profitability (B2U – Business-to-you.com, 2019). In this case, in order to stay competitive A2 Milk need to consider factors such as government policies and contract law. Government policies will affect the supply of milk. If government wants to decrease the supply of milk, farmers needs to decrease the extraction of milk. This will affect the profitability of the business. Another factor would be contract law. Contract law is enforced by the government to ensure that companies know what they should do and what they should not. For example, some countries will prohibit milk that are not natural or some criteria needs to be fulfilled. This will discourage business and affect their profitability. However, to increase the profitability of business, China-Australia Free Trade Agreement (ChAFTA) was introduced in December 2015, aim to support economic growth, job creation and higher living standards. So this creates an opportunity for the company to grow and prosper (Austrade.gov.au, 2019). Economic Economic factor are determinants of a certain economy’s performance. This factor will have impact on how profitable the company is due to its purchasing power on consumers and demand/supply in the economy as well as how company price their product and services (B2U – Business-to-you.com, 2019). The Australia milk industry economic can be affect by some of the following factors such as growth rate, purchasing power of consumers and demand for milk. There are research that shows the demand for A2 Milk is gaining traction among consumers due to the health benefits (A2 Milk Market: Global Industry Trends, 2019). In addition, since consumers are adjusting their lifestyle, company >GET ANSWER