Create an express web application

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Create an express web application for your project.

B. Configure the web application to run on your assigned port number.

C. The web application to be comprised of 3 static pages/views: ○ Index ○ About ○ Contact

D. Populate each static page with some basic content appropriate for your website.

Sample Solution

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Periodic Risk-Benefit Evaluation Report (PRBER

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also known as Periodic Safety Update Report or PSUR)

Assignment description:

In completing Assignment #3, Group Presentation for RGA6212, students will have the opportunity to:

Simulate the role of a Regulatory Affairs manager in preparing a PRBER/PSUR for a newly approved/marketed drug/device combination product
Demonstrate understanding of the relevant requirements for post-market risk: benefit profile evaluation as outlined in ICH E2C(R2) for drugs/biologics, especially in the US and EU
Demonstrate understanding of the concept of risk: benefit as it relates to drug/biologic lifecycle management and the application of pharmacovigilance as a whole
Conceptualize of what it would be like to work cross-functionally at a small-to-midsize biotechnology company to educate coworkers on the relevant regulatory guidance for post-market PVG reporting specifically with respect to the PRBER/PSUR requirement
As with assignment numbers 1 and 2, you are a Sr Manager of Regulatory Affairs at a small, emerging biotechnology company that has successfully developed a new, inhaled treatment for Parkinson’s Disease, called Inbrija. Your company is very small but despite this, the company has successfully obtained FDA and EMA approval to market Inbrijawithin the United States and EU!

As a seasoned Regulatory Affairs professional, you are aware that your company will need to continue to evaluate the Risk: Benefit profile of Inbrija while it launches into the global marketplace. A mandatory requirement in the US and EU is for the submission of the PRBER/PSUR which will include an in-depth analysis of the current Risk: Benefit profile for Inbrija. The new product has been on the market for just under a year and the International Birth Date (IBD) of the approval is on the horizon. You will use the IBD to trigger the timing of the submission of your PRBER/PSUR to the US and EU authorities.

Sample Solution

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Economic theory

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Q20-Q24. The market for cheap beer is characterized by the following supply and demand curves:
S: q = p + 3
D: q = −2p + 24
Suppose the government puts a $3 tax on cheap beer. 20. Before the tax, what are the initial equilibrium price and quantity in the cheap beer market?

  1. Using the point elasticity formula, calculate the price elasticities of supply and demand at the initial equilibrium.
  2. From the elasticities you calculated, do you expect the incidence of the tax to fall more heavily on the consumers or the producers? Explain.
  3. Calculate the effects of the tax on: (i) the price faced by consumers, (ii) the price received by producers, and (iii) the quantity traded in the market.
  4. Draw a graph showing the initial equilibrium and illustrating the impact of the tax. Label all curves and axes and all relevant prices and quantities. Identify in your graph the deadweight loss and the revenue raised for the government.

Sample Solution

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Any topic (writer’s choice)

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Find and read, the following article: Kelley, H. (1950). The warm-cold variable in first impressions of persons. Journal of Personality, 18 (4), 431.439.
Write a summary of the article describing the: IV, DV,  how the IV was manipulated, how the DV was measured, the theory, the hypothesis, the type of design, the participants, the findings, whether the hypothesis was supported, and any possible confounds that may have impacted the study. Please discuss any ethical considerations, if any, with this study as designed. Is there anything you wouldve done differently? This should be in paragraph form; do not use bullet points or lists. Finally, determine whether this is a between-subjects or within-subjects design (please state your decision) and consider whether you could convert the design to the opposing design. Why or why not? (For example, if you decide the design is a between-subjects design, then consider whether you could convert it to a within-subjects design. If you decide the design is a within-subjects design, then consider whether you could convert it to a between-subjects design.)