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

Discussion post #3-HCR577

Discussion post #3-HCR577

Due Apr 5 11:59pm
Available from Mar 15 until Apr 6
40 points possible
Discussion Topic: Module 3: Discussion PostModule 3: Discussion Post
Instructions
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 student, 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
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.”
View the discussion rubric
Click on Reply to post to the discussion.
Module 3 Discussion Rubric
Criteria
Ratings
Points
Initial Post
ExcellentThe post is comprehensive and fully answers the discussion prompt. Student used complete sentences, appropriate tone, and clear language.20 pts
GoodThe post is comprehensive, but does not fully answer the discussion prompt. Student used complete sentences, appropriate tone, and mostly clear language.10 pts
Needs Significant ImprovementThe posting is not comprehensive and does not answer the discussion prompt. Student used Incomplete sentences, inappropriate tone, and/or unclear language.0 pts
Criterion Score

/20 pts

Comment

Reply Post
ExcellentStudent posted the required number of relevant peer responses, meeting all requirements.20 pts
GoodStudent posted a response or responses but it was not relevant or did not significantly contribute to the discussion.10 pts
Needs Significant ImprovementStudent did not post a reply, or reply contained incomplete sentences, inappropriate tone, and/ or unclear language.0 pts
Criterion Score

/20 pts

Comment
Module 3 Discussion Rubric
Criteria
Ratings
Points
Initial Post
ExcellentThe post is comprehensive and fully answers the discussion prompt. Student used complete sentences, appropriate tone, and clear language.20 pts
GoodThe post is comprehensive, but does not fully answer the discussion prompt. Student used complete sentences, appropriate tone, and mostly clear language.10 pts
Needs Significant ImprovementThe posting is not comprehensive and does not answer the discussion prompt. Student used Incomplete sentences, inappropriate tone, and/or unclear language.0 pts
Criterion Score

/20 pts

Comment

Reply Post
ExcellentStudent posted the required number of relevant peer responses, meeting all requirements.20 pts
GoodStudent posted a response or responses but it was not relevant or did not significantly contribute to the discussion.10 pts
Needs Significant ImprovementStudent did not post a reply, or reply contained incomplete sentences, inappropriate tone, and/ or unclear language.0 pts

HCR 593 Applied Project Progress Report #4

HCR 593 Applied Project Progress Report #4

Progress Report #4 (15 pts)
  • Due Apr 12 by 11:59pm
  • Points 15
  • Submitting a file upload
  • Available until Apr 13 at 11:59pm
Progress Report must include updates on your project since your last progress report was submitted (or proposal for the first progress report). Use this opportunity to document your project’s journey. Some questions to consider: What are your plans for accomplishment within the following week and how have you scheduled time to accomplish it? Then, add a short reflection on your progress.
Rubric:
Ten (10) of the possible 15 points are for detailed progress reporting and planning.
Five (5) points of the possible (15) for personal reflection on your progress reporting and planning.
Each progress report must be unique to the progress you have made in the reporting period. Avoid cutting and pasting previous submissions. This is an opportunity to document and reflect on your path.
This template is in Word format for ease of reporting.
Reminder, Progress notes are not accepted late.

Scientific Poster- HCR 593

Scientific Poster- HCR 593

Module 12: Scientific Poster
Posters are a special type of presentation. When well designed, they are not simply journal papers pasted onto boards. Nor are they mounted sets of presentation slides. Rather, posters, when effectively designed, are something in between. Research posters summarize information or research concisely and attractively to help publicize it and generate discussion.
For a poster to communicate the work, the poster first has to orient an audience that is not seated, but that is standing. Often the audience has distractions of noise and movement from other people. Given those distractions, a journal article tacked onto a board fails as an effective poster because the audience cannot concentrate for a time long enough to read through the paper. In fact, given the distractions that the audience faces, many in the audience will not even bother trying to read a journal article tacked onto a board. The poster is usually a mixture of a brief text mixed with tables, graphs, pictures, and other presentation formats.
PowerPoint Presentation:
 Poster Format
1. First, the title of an effective poster should quickly orient the audience. ​
Here are some guidelines for poster titles:
1. Make the title the most prominent block of text on the poster (either center or left justify at the top).
2. Do not typeset the title in all capital letters (such text is difficult to read).
3. Use small words such as of, from, with, to, the, a, an, and and to separate details in the title.
While phrase titles are most common, some researchers effectively use sentence titles for posters that present one main result. In such titles, state the result in the title and capitalize the words as you would in a sentence. Because the sentence title is a stand-alone, as opposed to being part of a paragraph, the period is generally dropped.
2. Second, the poster should quickly orient the audience to the subject and purpose
 One good test is whether the audience recognizes the subject and purpose within 20 seconds of seeing the poster. Usually, a poster accomplishes this goal with a well-crafted title and with supporting images. Also, make sure that the type is large enough to be read and that enough contrast exist between the color of the type and poster’s background.
3. Third, the specific sections such as the results should be easy to locate on the poster
Once readers recognize what the work is, they decide how much energy to invest into the poster. For instance, many will read only the motivation for the work, the objectives (or goals) of the work, and then the final results. Others, who have a deep interest in the topic, will try to read the poster from beginning to end. Given these different approaches to reading posters, another characteristic of an effective poster is that specific sections are easy to locate.
4. Fourth, you should design the individual sections of a poster so that they can be quickly read.
Given the distractions that occur while reading posters in a symposium, the poster should not contain large blocks of text. Neither should the poster contain long sentences. If possible, the sections should rely on images: photographs, drawings, and graphs.
5. What software can I use to make a poster? Usually MS PowerPoint
Note:
  • Template choice is up to you
  • Single slide to contain your work
  • These are not to be printed – strictly digital for submission
A sample of a well designed poster
Layout of a typical poster.
A sample of a poorly designed poster
  • Posters rarely need an abstract
  • Text is dissolving into background
  • Graphs are too small and too many
  • Captions not aligned  with image
  • Too much wording – crammed into space
Resources:
 A sample template that you can modify.

HCR 593 Applied Project

HCR 593 Applied Project

Author Release (#15 pts)
  • Due May 1 by 11:59pm
  • Points 15
  • Submitting a file upload
Please complete the attached Author Release document for the placement of your applied paper on the upcoming CRM/Reg Sci web page “Hall of Fame.” If you do not want to allow your project to be posted, no problem! The form allows for that answer and is completed in total for the credit attached to it.
Please review questions and respond to all of them. If you have questions or comments regarding any part of this form, please ask the instructor before the due date.