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 […]
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 […]
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 […]
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 […]
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 […]
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 […]
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 […]
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: […]
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 […]
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 […]
