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 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 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 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 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. […]
HCR 577 CTD module 4&5 Assignment Module 5: CTD Modules 4 and 5 – due date Wednesday 15/2026 Due Wednesday by 11:59pm 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 […]
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. […]
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 […]
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 […]
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 […]
