Writing Assignment #2
RGA 6207 Electronic Common Technical Document (eCTD)
In completing Writing Assignment #2 for RGA6207students will have the opportunity to build upon theresearch conducted, as well as the foundationalknowledge developed in Writing Assignment #1. Thus,to complete Writing Assignment #2 please utilize theFDA approved pharmaceutical or biologic productselected in Writing Assignment #1. For WritingAssignment #2 please conduct an analysis of the typesof background information and data that would be required in Modules 2 & 3 of a Common TechnicalDocument (CTD) compliant submission to FDA. Wehave studied the content requirements for CTDModules 2 & 3 during Weeks 4 & 5 of the course.
In addition to providing a summary of the contentrequired in Modules 2 & 3 for your specifically chosenFDA approved product, your completed Writing Assignment #2 should also include the following:
? An explanation for whether the IntegratedSummaries of Safety (ISS) and Effectiveness(ISE) for your product would be included in CTDModule 2 or Module 5
? A description of the non-clinical and clinicalinformation that was likely incorporated by theproduct manufacturer in CTD Module 2
? Identification and synopsis of any Chemistry,Manufacturing and Controls (CMC)challenges/issues that were likely incorporatedby the product manufacturer in CTD Module 3
? Identification and synopsis of any quality associated challenges/issues that were likelyincorporated by the product manufacturer in CTDModule 3
You have to continue with BAXDELA which is used in assignment#1 (attached) and I have attached 2 PPTs if those help
Expert Solution Preview
Question: What is the objective of Writing Assignment #2 for RGA 6207 students?
The objective of Writing Assignment #2 for RGA 6207 students is to analyze the types of background information and data that would be required in Modules 2 & 3 of a Common Technical Document (CTD) compliant submission to FDA for a FDA approved pharmaceutical or biologic product selected in Writing Assignment #1. Students are expected to provide a summary of the content required in Modules 2 & 3 for their selected product and address specific questions related to Integrated Summaries of Safety (ISS) and Effectiveness (ISE), non-clinical and clinical information, Chemistry, Manufacturing and Controls (CMC) challenges/issues, and quality associated challenges/issues. The assignment builds upon the foundational knowledge developed in Writing Assignment #1 and content requirements for CTD Modules 2 & 3 studied during Weeks 4 & 5 of the course.
