Entries by James

HCR 577 Module 7

HCR 577 Module 7 HCR 577 Module 7 Discussion Topic: CURRENT TRENDS PAPERCURRENT TRENDS PAPER Current Trend paper can be any topic related to the pharmaceutical or food industry. You may select an article found in the Learning Materials if your topic is aligned with an article there.  You may also select a topic where […]

HCR577 Module 6 CTD

HCR577 Module 6 CTD HCR577 Module 6 CTD Due Apr 24 by 11:59pm Points 50 Submitting a text entry box, a website url, a media recording, or a file upload Available Mar 16 at 12am – May 1 at 11:59pm Combine your CTD.  Include the table of contents and each module in order for a complete submission. Create a cover letter […]

Course Reflection Assignment HCR 577

Course Reflection Assignment HCR 577 Due Monday by 11:59pm Points 100 Submitting a text entry box Available Mar 30 at 12am – Apr 29 at 11:59pm What is Reflective Writing? It is: A way of thinking to explore your learning and to express your views. An opportunity to gain self-knowledge, deepen your thought and understanding A careful consideration of what you […]

HCR 577 Course Reflection

HCR 577 Course Reflection Due Monday by 11:59pm 4/27/2026 Points 100 Submitting a text entry box Available Mar 30 at 12am – Apr 29 at 11:59pm What is Reflective Writing? It is: A way of thinking to explore your learning and to express your views. An opportunity to gain self-knowledge, deepen your thought and understanding A careful consideration of what you […]

HCR 577-Final Exam

HCR 577-Final Exam Points 125   Questions 5   Available Apr 10 at 12am – May 2 at 11:59pm   Time Limit None Instructions The final exam consists of five (5) Essay Questions. In you answer for each question provide 3 paragraphs (4-5 sentences) to answer the question topic. Include at least 3 references for each question. Each question […]

HCR 577 Module 5: CTD Modules 4 and 5

HCR 577 Module 5: CTD Modules 4 and 5 Due Wednesday by 11:59pm- 4/15/2026   Points 50   Submitting a file upload   Available Mar 18 at 12am – May 1 at 11:59pm Complete CTD – Modules 4: Nonclinical/technical requirements & 5: Clinical Studies & Reports; Benefit-Risk Information. Refer to Module 2 References in the Learning Materials Folder for specific instructions […]

HCR577Discussion Post Module 5

HCR577Discussion Post Module 5 Discussion Topic: Module 5: Discussion PostModule 5: Discussion Post Instructions Benefit Risk The discussion this week is a bit different that previous discussions. This discussion has three (3) parts. These include (1) Identifying/listing 3 benefit risk dimensions and then discuss benefit risk. (2) For your Peer review, choose two dimensions identified […]

Applied Project Reflection Assignment- HCR 593

Applied Project Reflection Assignment- HCR 593 Module 10: Applied Project Reflection (100 pts) Due Sunday by 11:59pm Points 100 Submitting a text entry box or a file upload Available until Apr 16 at 11:59pm Applied Project Reflection Instructions The Applied Project is the culmination of the Regulatory Science Program. In this course, you applied the concepts learned throughout the program to a […]

HCR 593 Final AP submission

HCR 593 Final AP submission Module 11: HCR 593 Final Applied Project Submission (250 pts)*** THIS IS IT!! 🙂 Due Apr 19 by 11:59pm Points 250 Submitting a text entry box or a file upload File Types doc and docx If you have made it to this page and are ready to submit your project, CONGRATULATIONS for making it to the […]

HCR 577 Summary Group 4 Project 2

HCR 577 Summary Group 4 Project 2 Summary Module 5: Group Assignment: Project Management Steps to Ensure a Successful Submission Due Thursday 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. […]