HCR 577 Group 4 assignment 2

HCR 577 Group 4 assignment 2

Module 5: Group Assignment: Project Management Steps to Ensure a Successful Submission
  • Due Apr 16 by 11:59pm
  • Points 100
  • Submitting a file upload
  • Available Mar 18 at 12am – Apr 17 at 11:59pm
Your team (same groups as the country presentation) is responsible for the project management of the submission your company’s NDA to FDA. The market for your drug is highly competitive therefore meeting the timelines is critical. Prepare a timeline and assign roles and responsibilities to specific team members, as listed.
  • Quality Control
  • Validation Engineering
  • Formulation
  • Manufacturing
  • Regulatory
  • Quality Assurance
  • Facilities
  • Logistics
For Week 5, prepare a presentation to share with the development team. Show in the slides how this approach would be successful.
Provide 3-5 topics / questions where the FDA may request additional information and how you would manage this request.
Summary
Prepare a 1 page summary, ADA style, for your proposal to be submitted with your presentation. Submission to FDA: Dec 2027

Guidelines AP HCR 593

Guidelines AP HCR 593

Given the complexity of the Applied Project, a sample outline is given below. Although every research project
may show different degrees of variability and divergence from the outline given below, nonetheless, it should
be used as a guide. The applied project consists of the following components:
  • Title Page
  • Abstract (required to be added but only in the DRAFT 2 and at the final submission).
  • Chapter 1 (Introduction)
  • Chapter 2 (Background & Rationale – the review of the literature that supports the purpose and aim of the project)
  • Chapter 3 (Methods)
  • Chapter 4 (Results; note that the deliverable of your project may have to be briefly described here and then added as an appendices to the project)
  • Chapter 5 (Discussion on the results and how your project “FITS” in the literature that you reviewed in the background. Reminder, in-text citations are REQUIRED for a successful Discussion Chapter).
    • Conclusion required to conclude the overall project briefly.
  • References
  • Appendices
Table of Contents: As you are developing your draft, you can “dummy up” your table of contents page without
page numbers for the TOC entries. It is likely that the insertion of page numbers next to the TOC entries will
be one of your last tasks before submitting the document. When you do revisions, be sure to check and correct
the TOC each time you revise, as it is likely to change.
Abstract is BEFORE the TOC
Chapter                                       Page #
Chapter 1 (Introduction)              s
Chapter 2 (Background & Rationale)   t
Chapter 3 (Methods)                   u
Chapter 4 (Results)                     v
Chapter 5 (Discussion)               w
Sub-section: Chapter                  x
References                                    y
Appendices                                   z
Note you can add page numbers for the images, figures, etc.. To clarify, figures, tables, images ARE required but adding them to the TOC is not.
he introduction should address the following:
  • Background and need for the projectThis section should focus on the background and importance of your project. A brief historical significance is generally warranted with with such topics as epidemiology, etiology, or regulatory mechanisms.  This section should be a justification for your research intent.
  • Definition of Terms—May be bulleted/enumerated
  • Statement of Research Question/Research Objective
Important points to remember about your introduction:
The introduction should include all articles and references that pertain to the background. Any article that describes the mechanisms, causes, treatments and other aspects belongs in the introduction and not in the lit review.
Keep the introduction concise. Remember that people who are going to be reading your paper want to know that you know the information, but do not necessarily want to see every minute detail, unless it will help you answer your project’s research question.
EXAMPLE 1:  Points to Consider in developing an introduction
The project is to develop a meta-analysis for the following topic: “Acupuncture shows improved thyroid function in patients with Hashimoto’s Thyroiditis.”
  • What is Hashimoto’s Thyroiditis
  • Epidemiology of Hashimoto’s
    Susceptible populations and prevalence
    Male vs. Female?
    Specific ethnic populations?
  • Etiology: What causes Hashimoto’s Thyroiditis
    Genetic Factors
  •  Environmental Factors
  • Infectious factors
  • Pathology: Structural and functional changes in the body caused by Hashimoto’s
  • Clinical Presentation: How the patient presents
  • Treatments: Discuss “Briefly” Medical & Surgical interventions
In the last paragraph, state briefly how acupuncture has been helpful in similar conditions (hormone abnormality) and thus state your objective. This is basically a justification of your research.
Example
“Given the vast improvements of hormonal imbalances with acupuncture, coupled with the long term side effects of medical and surgical interventions in treating Hashimoto’s, we hope to show that through the metanalysis, acupuncture may provide an alternative treatment in normalizing thyroid hormones in Hashimoto’s Thyroiditis and improve clinical outcomes.”
  • Problem Statement: discuss the shortcomings of current treatments such as side effects of medications, invasiveness of different surgeries, etc. This will lead you to introduce your project as an optional treatment modality and will guide the reader to your research intent.
  • Purpose of Study: How does your study address the problem(s)?
  • Null and Alternate Hypotheses (if applicable): From your proposed study, what are all of the possible outcomes. Null and alternate hypotheses should be worded such that they are fully inclusive of all possibilities.
EXAMPLE 2: Sample completed introduction
INTRODUCTION
Statement of the Problem
The National Healthcare organization (NHO) has been recognized all over the world as a pioneer in the delivery of high-quality rehabilitation and long-term care. The goal of the organization is to offer a complete range of extended health care services which have been designed in order to maximize the independence and well-being of patients of differ is committed to meeting the needs of patients via a multidisciplinary approach, putting into combination high-quality patient care, together with cost-effective services. As presented on the website, NHO (2009) offers services to more than 80 long-term health care facilities.
So as to be viewed as a high-quality facility, several standards when it comes to care should be measured accordingly. One of the standards points to the weight loss rate among different patients. NHO has eventually set a goal below 5% of the patients with significant weight loss in every center for every quarter, along with recent weight loss rate that is way above the so-called acceptable range. It is in the best interest of every employee to be able to reach that goal. The loss in weight may have an influence on several aspects involved in patient care including mobility, skin breakdown, and the overall amount of staff time needed for patient care. The mentioned complications may also have an impact on the facility reputation, scores and bonuses of the employee. Unnecessary weight loss or that without any intervention may also prove to be a ground for state violations, fines as well as potential expensive lawsuits from the families reporting neglect.
An Objective of the Research
Several interventions are currently being made available to the NHO staff in order to help in preventing weight loss. Still, with several medical record observations, several of these interventions seem to be highly ineffective. At the same time, there are also some interventions that are commonly used which have been debated within the medical community. By taking into account some published research in the past, and doing some in-house analysis, the data may contribute to having an enhanced policy. Identifying which interventions can prove to be highly effective can also save the staff some money and time from the administration of treatments which generally do not work, thus allowing the staff to be able to focus on intervention methods that are worthwhile.
Module 4: Troubleshooting as your prepare your paper
POINTS TO WATCH OUT FOR:
1) Do not make assumptions in your project and paper if you cannot provide a proper reference: Example: “Western Medicine has many side effects in treating Hashimoto’s and therefore TCM provides an alternative treatment modality.”
2) Personal opinions should be avoided, unless it is part of an intellectual statement based on substantiated  documentation.
3) Avoid first person.
Not acceptable:
Western Medical practices have failed to treat patients with Hashimoto’s and therefore I feel TCM is an acceptable treatment modality which can replace pharmaceutical treatment. 
Acceptable:
While data for the past several decades have shown that thyroid replacement remains the mainstay of treatment for Hashimoto’s (reference), it should not be regarded as the sole treatment modality. Recent evidence in Chinese Medicine has shown striking results that should be taken into consideration. This can be further evident by the recent data obtained in this study that shows TCM has a significant improvement in outcomes with Hashimoto Thyroiditis patients. This suggests that patients with Hashimoto’s Thyroiditis should also be exposed to the data regarding TCM treatments with HD and allows them to make the ultimate decision in their treatment course. 
4) Try not use company websites, Wikipedia and pharmaceutical sponsored publications as references. These are often not accurate or biased in their data representation.  In the case of a novel and current applied project ideas, such as remote based monitoring during Covid 19, peer-reviewed literature may not yet be available. 
5) Epidemiological data such as that provided by the World Health Organization (WHO) website should only be used as background in your introduction. (20% increase in Hashimoto’s in US compared to 40% increase in Asia)
6) Avoid using “shock value” statements. Example: Pharmaceutical interventions in Hashimoto’s disease should be stopped and replaced with TCM.
7) Be wary of the words you choose to use. Scientific/research writing is different than writing in literature. Scientific/research writing should be short and concise.
8) Every word used in a scientific/research work has implications and therefore should be SCRUTINIZED.
Example:
a) Be careful when you use the word TREAT VS CURE.
b) Be careful in stating treatment vs. prevention vs. slowing of progression. Each of the aforementioned words has different clinical implications.
c) Be wary of treating a disease vs. symptomatic treatment
 
Module 4: Learning Materials – Literature Review 101 
You have identified your project research question – now it is important to see who else may have had the same idea! The review of related literature indicates what is known about the problem or topic. It’s function is to educate the reader about the area that was studied. It is a summary of the relationships and differences among relevant reports and studies. The review should flow in such a way that the least related references are discussed first and the most related references are discussed last. This is placed right before your research question/hypothesis.
A literature review asks: What do we know – or not know – about this particular issue/ topic/ subject?
How well you answer this question depends upon:
  1. the effectiveness of your search for information
  2. the quality & reliability of the sources you choose
  3. your ability to synthesize the sources you select
Decide the scope of the review
The scope of the review refers to the years and amount of knowledge being managed. Depending on the scope that is going to be presented, the comprehension of the work could change. So, it is important to know and decide the approach that the author wants to give to the subject, but it can also depend on the research and topic, needing more sources to be explained or just a little more depth into the subject.
Select the correct databases for searches
The databases on a literature review will give some background into the work, also giving some improvement to the style and formatting being used. It is important to always look for databases that are related to the subject that is being talked about, with specific relation to the discipline of the review.
Start the searches into the literature
This is how the work begins; from this, the whole paper will start to have to mean, so it is important to follow some rules:
  • Review the abstracts works of the discipline related to the subject being presented to save time.
  • Avoid dead-end searches in databases by writing down every search being finished.
  • Use bibliographies and references of the research in order to find more works on the discipline.
  • Ask experts in the fields (if possible) to give advice on the discipline, or just point out the missing important works left to review.
Reviewing the literature
When reviewing the literature and research as a whole, there are some questions that would help the author to have and portray all the findings in a better and more understandable way:
  • What was the question of the research study? What were the cited and referenced authors trying to discover or prove? Was the research of the cited author being funded by an influencing source?
  • What were the methodologies used in the cited works? Analyze the whole literature, all the sample, variables, results, and conclusions.
  • Was the research completed? Did it get to a point, proving or discovering something?
  • Our studies in conflict with the one being presented? Is the other more influential or giving a proved answer?
  • Are the cited authors respected and viewed with prestige and his work with approval?
Resources:
Loading media…
(Part One) Youtube Video
Citation Management Tools help you collect, organize and manage a personal database of book and article citations. Managing references helps to create bibliographies and/or format papers with in-text citations and a bibliography in the style of your choice. See https://libguides.asu.edu/health/citations (Links to an external site.)https://libguides.asu.edu/health/citations?tiq=t
 
 
Attachments
 
 
Module 4: Learning Materials: Literature Review – Assignment Overview
Assignment Overview
Assignment Overview
Assignment Overview
Literature Review Includes
Background and Rationale Chapter (Review of the Literature that supports the aim, research questions and supports the PURPOSE of the study. This is a thorough review of the literature to support the PURPOSE of the study).
Background & Rationale – A coherent, comprehensive review of literature that is current on your topic, supporting the purpose of the study, and ends with the method you will take.
This review is a coherent review of the literature directly related to the concepts and problem under study, followed by an explanation of how your research question grows out of that review, that is, showing how you identify your own research focus in terms of “gap” in previous research. The purpose of the literature review is to know what others have discovered before conducting your own investigation and to ground your study in a particular context of what is known about a subject in order to establish a foundation for the topic (or question) being researched.
The purpose of this assignment is to facilitate your abilities to research a topic of study and learn to:
  1. identify and formulate an inquiry question that defines what you’d like to learn
  2. search for and locate literature (e.g. Journal articles) using library and internet resources
  3. analyze information found in educational journal articles
  4. synthesize new knowledge into a written literature review, and
  5. establish context for your inquiries
  6. Your literature review will help set the foundation of your project. Are there other projects like yours in the literature? If so, were they done in the past 5 years, 10 years,  older? If not, is your idea novel and innovative?
  7. Instructions
  8. Conduct a review of the literature on your topic.
  9. Write a Literature Review on your selected capstone topic. It should be as complete of a literature review as is possible on the articles you’ve selected.
  10. Include  journal articles and regulations you located on your topic (journal articles are required – regulations can not be used alone – we need to know how the regulations are impacting the experts or the field.
  11. Format your paper (Length: 5 pages minimum) in APA version 7 style. Carefully review APA V7 including reference listings.
  12. Steps to complete your literature review
    Outline for writing your literature review:
    Attachments:
    Attached you will find the information planner, a sample template to help you log your articles, and more notes on about conducting literature reviews.
    1. Formulate an inquiry question that specifically describes what would like to know about your capstone topic (you’ve done this in you Introduction draft, but you can always refine your inquiry questions after you know more about your area through reading the literature).
    2. Search for and locate journal articles through the library (Links to an external site.) that are relevant to your topic.
    3. Review article abstracts and skim articles to determine if they correspond specifically with your aim  and inquiry
    4. Select journal articles and download or htmf or create pdfs them for your own records
    5. Make notes on your research log (IMPORTANT!) AS YOU (#6)
    6. Read your articles and begin to sort and classify them into themes
    7. Organize your articles by sorting and classifying their findings in a meaningful way, always considering your original topic and inquiry question.
    8. Write an outline for your literature review.
    9. Write your review.
    10. Revise your review.
Lit Review Video
Interesting video that covers how to do a lit review
Module 4: Examples of Students Literature
Reviews
Attached files:
  • Please note that we have updated the Background and Rationale as well as Draft 1 TEMPLATE since these Capstones / Applied Projects were submitted. Therefore, each section may not appear precisely as your template describes. Nonetheless, you can note the level of detail in collecting the literature to support the student’s independent project’s AIM and research questions.
  • Final Submission Example AP.pdf
  • Note that this submission has “Background” identified before “Introduction.” Although these two sections are not identified in the order prescribed, each sections cover the introduction and background requirements well.
  • Although this is focused on background sections, note, however, the excellent example of images/tables in results.

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Discussion Post 3 HCR 577

Discussion Post 3 HCR 577

Due Apr 5 11:59pm
Available from Mar 15 until Apr 6
40 points possible
2 Replies, 2 Unread
2 Replies, 2 Unread
Discussion Topic: Module 3: Discussion Post Module 3: Discussion Post
Quality Testing of New Drugs
Discussion this week is two parts:
List and explain 2 quality control tests required for IND and new drug product submissions.
To earn full points your posts must be submitted on time. In your initial post  you must list and explain two quality control tests for new drug product. In your Peer response you must pick 2 quality control tests from two different students, explain the purpose of these quality control tests and discuss if these are sufficient to demonstrate drug manufacturing is controlled.
BACKGROUND
  • Identity
  • Strength
  • Purity
Pharmaceutical Chemistry
Just let me know if you can open the links. thanks, Marisol
Pharmaceutical Microbiology
Wednesday by 11:59 p.m.
 The initial post is worth up to 20 points.  Initial posts should be at least 2 paragraphs, with each paragraph being at least 4-5 sentences in length.
Peer Responses
Respond to posts by two of your peers with additional ideas, questions, or thoughts. There is no length requirement, however responses should contribute substantially to the discussion. Make sure posts are engaging by asking questions, challenging each other in a professional manner, and providing new information for others to review and think about. You are expected to communicate respectfully and practice good netiquette in all course interactions. Remember that APA-style citations/references for any work or thoughts that are not your own are required.
Due on Sunday by 11:59pm.
Grading
Initial posts are worth up to a total of 20 points, and peer responses are worth up to an additional 20 points. See the grading rubric for a better understanding of how to get your best grade.  To access the rubric, click on the three vertical lines at the top of the page and select “show rubric.”
Module 3 Discussion Rubric
Criteria
Ratings
Pts
This criterion is linked to a Learning OutcomeInitial Post
20 ptsExcellentThe post is comprehensive and fully answers the discussion prompt. Student used complete sentences, appropriate tone, and clear language.
10 ptsGoodThe post is comprehensive, but does not fully answer the discussion prompt. Student used complete sentences, appropriate tone, and mostly clear language.
0 ptsNeeds Significant ImprovementThe posting is not comprehensive and does not answer the discussion prompt. Student used Incomplete sentences, inappropriate tone, and/or unclear language.
20 pts
This criterion is linked to a Learning OutcomeReply Post
20 ptsExcellentStudent posted the required number of relevant peer responses, meeting all requirements.
10 ptsGoodStudent posted a response or responses but it was not relevant or did not significantly contribute to the discussion.
0 ptsNeeds Significant ImprovementStudent did not post a reply, or reply contained incomplete sentences, inappropriate tone, and/ or unclear language.
20 pts
Total Points: 40

HCR 593 Applied Project Draft 2

HCR 593 Applied Project Draft 2

Discussion Topic: *Please Read* prepping for Draft 2 and an extra day given for submission*Please Read* prepping for Draft 2 and an extra day given for submission
Greetings all,
I pushed back the due date for Draft 2 to Monday, April 6th, end of day (from Sunday, April 5th) due to multiple holidays later this week and over the weekend.  I will continue to begin my review on Monday morning; however, if you are ready to submit, please feel free to do so.
***If this will give you EVEN ONE EXTRA REVIEW, I encourage you to do that! Please. The hardest part of an independent project is taking the outside perspective to read it from outside and verify flow and alignment.
As I said a few times, the most common issue in Draft 2 submissions historically are listed below to help you:
1. Results do not specifically answer the research questions or are not clear on how they answered the research questions.
2. Results are not cited with the articles/gov documents that were used to create them. (I CANNOT TELL YOU HOW COMMON THIS IS AND HOW INCREDIBLY IMPORTANT IT IS TO CORRECT THIS/VERIFY THIS. Why? Well, this is the whole point of the project: to instruct your readers on how you validly and reliably created a unique, important finding that is valid based on your scientific inquiry/approach.
3. Past tense for both Results, Discussion, and Methods.
4. When students treat this Draft 2 as a full final submission, there is more refinement and preparation in the actual final submission. BECAUSE, although it may not feel like the last review before the very end, this is truly the final review before the final submission. 
5. Rarer than the first FOUR, but on occasion, there is a submission that does not have a table or image in the Results, which is required (and easily used again in the poster 🙂
I sincerely hope this helps. I am very excited for each of you to be this far (and this close!).
Gentle Reminder: I will not do a full review before this DRAFT 2 submission, BUT I AM HAPPY TO ANSWER QUESTIONS and/or hold a formal or informal meeting (Zoom or phone) to discuss any questions, clarifications you may have!!! All you have to do is reach out and ask, and I am there for you!

Module 4: CTD HCR 577

Module 4: CTD HCR 577

  • Points 50
  • Submitting a file upload
  • Available Mar 16 at 12am – Apr 10 at 11:59pm
Complete Module 3 of the CTD. Refer to Module 2 References in the Learning Materials Folder for specific instructions and requirements for the CTD.  Your assignment requires that you add Module 3 to Module 2 for your submission.  That includes updating the table of contents to include Module 2 & 3.
Rubric
CTD Module (1)
Criteria
Ratings
Pts
This criterion is linked to a Learning OutcomeTable of Contents Updated
For each CTD Module provide an updated table of contents to reflect the sections of the CTD.
10 ptsExcellentCompletes all sections of CTD Module 2 & 3 correctly.
8 ptsGoodCompletes CTD Module 2 & 3 with only one error or one incomplete line.
0 ptsNeeds ImprovementCTD Module 2 & 3 is incomplete without explanation.
10 pts
This criterion is linked to a Learning OutcomeCTD Format
CTD Module aligns with table of contents
15 ptsExcellentFollows CTD Module 2 & 3 format, spelling and grammar correct with no more than 2 errors.
10 ptsPoorDoes not follow CTD Module 2 & 3 format.
15 pts
This criterion is linked to a Learning OutcomeSummary Content
25 ptsExcellentProvides studies and product information under appropriate headings
15 ptsGoodSome studies and product information are not under appropriate headings
0 ptsPoorDoes not provides studies and product information under appropriate headings
25 pts
Total Points: 50

Module #1 CTC Assignments- HCR577

Module #1 CTC Assignments- HCR577

Module 1: Overview of Common Technical Document (CTD) Assignments
CTD Module Preparation
In this class, you are preparing a submission for the FDA. You know that the FDA requires the submission in the Common Technical Document (CTD) format.  This format is new to your company.  You want to ensure that management has time to review and approve each section to prevent delays due to the need to address feedback and comments.
You will use ADA formatting for your CTD.  Each Section must be completed with information received in class or by researching your assigned drug.Refer to the classroom materials and online guidelines and guidance for CTD formatting.
  • During Module 1/Week 1, you will identify the drug for this CTD drug in the discussion.
  • During Modules/Weeks 2,3,4 & 5, you will use your assigned drug to complete each of the Modules.
  • For Module 4 & 5, research types of studies that may be performed during clinical studies.  List at least 3-5 studies for these sections.
  • In Module 6, finally you will assemble the CTD into a single document.  Then, preparing for submission, you will prepare a 1 page cover letter to the health authority and add this to the CTD and submit to complete the assignment.

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CTD in the Course Schedule
Week
Topics/Lessons/Course Outcomes
Activities
Assignments
Mod 1  Week 1
Global Regulatory Affairs Overview – regulatory authorities, regulations, stakeholder roles & responsibilities (Outcomes 1, 3 & 7)
Discussion (choose drug)
Mod 2 Week 2
Regulatory Framework, CTD – Module 2: Quality Summary (Outcomes 2, 3, 4, 5)
Discussion: Medical Product Development Process in US
Mod 3 Week 3
CTD – Module : Quality (Outcomes 2, 3, 4 & 5)
Discussion: Quality Control Tests
Mod 4 Week 4
CTD – Modules 4: Nonclinical/technical requirements & 5: Clinical Studies & Reports; Benefit-Risk Information (Outcomes 2, 3, 4, 5, 6 & 7)
Midterm
Mod 5 Week 5
CTD Submission Process – US & EU (Outcomes 4 & 5)
Discussion Board 4 – Risk/Benefit
Group PowerPoint & Summary
Mod 6 Week 6
Regulatory Overview: Asia, Canada & Emerging Countries (Outcomes 6 & 7)
Discussion Board 5 – Biosimilars
Combine CTD modules to prepare for submission with cover letter to the health authority
Mod 7 Week 7
Global Trends, Ethical and Cultural Concerns, and Issues (Outcomes 1, 3 & 6)
Paper – Current Trends and Issues in the conduct of global clinical trials
Course Reflection
Mod 7 Week 8
Final Exam (Outcomes 1 – 7)
Final

learning material module 2 HCR577

learning material module 2 HCR577

Overview
The Common Technical Document (CTD) was designed to provide a common format between Europe, USA, and Japan for the technical documentation included in an application for the registration of a human pharmaceutical product. The CTD dossier is divided into five main modules: Module 1 – Administrative information and prescribing information; Module 2 – Overviews and summaries of Modules 3–5; Module 3 – Quality (pharmaceutical documentation); Module 4: Non-clinical reports (pharmacology/toxicology); Module 5: Clinical study reports (clinical trials). Detailed guidelines are provided describing the content of each module and the majority of submissions must now follow the CTD format for submission dossiers.  Reference:  https://www.researchgate.net/publication/272224035_An_overview_of_the_Common_Technical_Document_CTD_regulatory_dossierLinks to an external site.
 
Learning Objectives
By the end of this module, students will be able to:  
  1. Integrate documents, data, and reports required in modules 2, 3, 4 and 5 of the Common Technical Document (CTD).
  2. Compile the global modules of the CTD for marketing approval.
  3. Compare and contrast the new medical product regulations between the United States (U.S.) and the European Union (EU).
  4. Evaluate ICH guidelines as they apply to the formatting and submission of the CTD.

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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)
Criteria
Ratings
Pts
This criterion is linked to a Learning OutcomePowerPoint
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.
50 pts
This criterion is linked to a Learning OutcomeSummary Format
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.
20 pts
This criterion is linked to a Learning OutcomeSummary Content
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.
30 pts
Total Points: 100

Module 4: CTD Module 3 Quality-HCR577

Module 4: CTD Module 3 Quality-HCR577

Module 4: CTD Module 3 Quality
  • Due Mar 31 by 11:59pm
  • Points 50
  • Submitting a file upload
  • Available Mar 16 at 12am – Apr 10 at 11:59pm
Complete Module 3 of the CTD. Refer to Module 2 References in the Learning Materials Folder for specific instructions and requirements for the CTD.  Your assignment requires that you add Module 3 to Module 2 for your submission.  That includes updating the table of contents to include Module 2 & 3.
Rubric
CTD Module (1)
Criteria
Ratings
Pts
This criterion is linked to a Learning OutcomeTable of Contents Updated
For each CTD Module provide an updated table of contents to reflect the sections of the CTD.
10 ptsExcellentCompletes all sections of CTD Module 2 & 3 correctly.
8 ptsGoodCompletes CTD Module 2 & 3 with only one error or one incomplete line.
0 ptsNeeds ImprovementCTD Module 2 & 3 is incomplete without explanation.
10 pts
This criterion is linked to a Learning OutcomeCTD Format
CTD Module aligns with table of contents
15 ptsExcellentFollows CTD Module 2 & 3 format, spelling and grammar correct with no more than 2 errors.
10 ptsPoorDoes not follow CTD Module 2 & 3 format.
15 pts
This criterion is linked to a Learning OutcomeSummary Content
25 ptsExcellentProvides studies and product information under appropriate headings
15 ptsGoodSome studies and product information are not under appropriate headings
0 ptsPoorDoes not provides studies and product information under appropriate headings
25 pts
Total Points: 50

AP submission Draft 2- HCR 593

AP submission Draft 2- HCR 593

Applied Project Paper Draft Submission #2 (50 pts)
  • Due Apr 5 by 11:59pm
  • Points 50
  • Submitting a file upload
NOTE: Instructors will return any draft #2 submission with a clear warning if there is no evidence of advancement from the previous draft submission. Any and all corrections or clarification requirements requested in the last submission draft must be addressed clearly. (Note that the word “addressed” here can mean 1. suggestion taken or 2. suggestion not taken but a new direction taken to satisfy the instructor’s comment). In other words, it is critical that there has been enough progress that the final submission is now in sight with this version submission. This is critical for your opportunity to pass this class on time. 
Submission: See rubric
 (this version includes sections in Results and Discussion with reminders on inclusion requirements however please use the modules to verify you have included all necessary points that each chapter requires).
A complete draft of the project, which requires Chapters 1 through 5, must be included.
The focus of this review is on Results and Discussion with a review of the updates to Methods and alignment throughout.
The point of this review is as follows (to verify…):
  • Feedback incorporated and addressed for the Methods section
  • Table of Contents present
  • Abstract present (if not yet completed with full results and impact)
  • Results present
    • The aim statement is presented at the start of the chapter
    • Results at this stage are present and complete or almost complete (DIRECT answer to the research questions).
      • If literature review as a method: clear what information was extracted from the literature that met inclusion/exclusion
      • articles/regulations that met inclusion/exclusion are in a table and presented to the reader
      • use appendices as needed for applied projects such as SOPs, Regulation comparison etc.
      • If the survey, responses to the survey along with the reason each question is applicable to the research questions to answer the aim/thesis.
    • At least one (usually more) visual (i.e., table/figures, etc). is required in the final submission.
  • Discussion, if not also the conclusion is present
    • The discussion starts with the Aim Statement (again) and whether the aim was met and how.]
    • Includes a discussion of how your results “fit” into the literature that you reviewed in the background.
      • This would not be possible without in-text citations. That is a critical part of this process.
      • You must compare and contrast your findings with others. This is required.
      • Limitations of your research (all research has them)
      • Future direction – what should future researchers do to push this research forward for the benefit of society or industry (or academia)?
All tenses will have to be changed to past tense before final project submissions. 
This review is NOT:
  • focused on the Introduction and Background,
    • Although alignment is verified between each chapter with your clear aim statement (at the start),
  • focus on APA formatting, as this will be incorporated into the first and final review. It is up to the student researcher to verify APA formatting.
Have questions? Please ask and take the initiative and responsibility for your success. 
Rubric
DRAFT 2
Criteria
Ratings
Pts
This criterion is linked to a Learning OutcomeAlignment
Alignment is evident in each chapter. Some examples of this: research questions are direct (valid) from aim/purpose of the project. Method is introduced in Background chapter and evident in the aim/purpose statement. Research questions are answered in the results. Research questions are clear on how they are addressed and how they are related to results.
5 ptsFull Marks
0 ptsNo Marks
5 pts
This criterion is linked to a Learning OutcomeMethods updated per feedback
Methods will be reviewed. Consider all feedback from draft 1. Verify Validity and Reliability of the details here .
5 ptsFull Marks
0 ptsNo Marks
5 pts
This criterion is linked to a Learning OutcomeResults
Starts with Research Aim/purpose. Results have description of ONLY the results of the project. Results are reliable in method (can be duplicated based on the method outlined). For example, exactly what the answers are to the research questions are evident clearly to the reader. Includes at least one or more figures/table/image. If this project is a lit review as a method, the articles that met inclusion/exclusion are provided clearly in the results.
15 ptsFull Marks
0 ptsNo Marks
15 pts
This criterion is linked to a Learning OutcomeDiscussion
The discussion starts with the research aim/purpose and research questions. Identifies whether the aim was met in the project. Discussion “discusses” the results. Discussion “discusses” how the results fit in the literature that is outlined in the background literature. For example, how is the identified “gap” filled with the research, results are compared and contrasted with literature in background (in-text citations are plentiful in this chapter). Limitations of the literature are evident, future research direction is listed.
25 ptsFull Marks
0 ptsNo Marks
25 pts
Total Points: 50