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