HCR 577: Module 2- GROUP PROJECT
HCR 577: Module 2- GROUP PROJECT
- Due Apr 1 by 11:59pm
- Points 100
- Submitting a file upload
- Available Mar 16 at 12am – Apr 6 at 11:59pm
Scenario
Your team is responsible for determining the country most suitable for marketing your product. You and your team are responsible to inform your company of your submission timeline and market strategy. You do this by preparing a presentation to senior leadership. Your presentation includes the countries that you will target to include the US and your selected country. You will use the drug you selected to build your CTD (select one of the drugs from a member of your team). Once you have identified your drug you will create a fictitious name, do not use the marketed name of the drug. Essentially, each group will present a different drug and different country. The market for your drug is highly competitive, therefore, including the timelines for submission is critical. Generally, a submission requires 9 to 12 months to prepare; data from drug studies often are available 3 months prior to submission. The planned date of submission to your country is December 2027.
Teams
Please work together in the following teams to compare your assigned country with the US.
Please combine your efforts for 1 submission.
Instructions
Provide a list of 3-5 topics / questions about which the health authority from your assigned country (or the FDA) can request additional information. These topics should be represented in a slide in your PowerPoint presentation.
Explain how you would manage this information request. The questions usually arise from product risks, such as efficacy, container closure, stability studies, degradation of drug product, human factors, and whether the drug delivery system is difficult to use (i.e., inhaler, syringe, vial with stopper, IV, etc).
Create a Power Point presentation to persuade your company’s leadership team to select your assigned country over the U.S. Explain how and why this approach would be successful. Submit 1 presentation per team
Write a one-page summary of the things you covered in your presentation. APA style required. Submit 1 summary paper per team. SUMMARIES THAT DO NOT MEET THE 1 PAGE REQUIREMENT – TOO SHORT TOO LONG WILL BE CONSIDERED INCOMPLETE AND POINTS WILL REFLECT THIS.
Submit your files in Canvas.
Rubric
Country Comparison PowerPoint & Summary (1) (1)
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Criteria
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Ratings
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Pts
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This criterion is linked to a Learning OutcomePowerPoint
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50 ptsExcellentPowerPoint presentation has a cover sheet, 1 slide with recommendation, 3-4 slides discussion, 1 slide conclusion, 1 slide with references. Presentation skills.
35 ptsGoodany 1 of these missing: PowerPoint presentation has a cover sheet, 1 slide with recommendation, 3-4 slides discussion, 1 slide conclusion, 1 slide with references. Presentation skills.
10 ptsNeeds Improvement2 or more missing: PowerPoint presentation has a cover sheet, 1 slide with recommendation, 3-4 slides discussion, 1 slide conclusion, 1 slide with references. Presentation skills.
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50 pts
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This criterion is linked to a Learning OutcomeSummary Format
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20 ptsExcellentFollows APA format, spelling and grammar correct with no more than 2 errors.
10 ptsGoodFollows APA format, spelling and grammar appropriate with no more than 3 – 5 errors.
0 ptsPoorDoes not do or does not following instructions and does not meet requirements.
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20 pts
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This criterion is linked to a Learning OutcomeSummary Content
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30 ptsExcellentProvides a detailed summary of product and supports with 3 or more references, one of which must be from the ASU library. Meets 1 page requirement.
15 ptsGoodGeneral description that covers points, includes at least 2 references, one must be from the ASU library. Meets 1 page requirement.
0 ptsPoorDoes not do or work turned in does not meet assignment requirements. Does not meet 1 page requirement, either too long or too short.
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30 pts
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Total Points: 100
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