Writing Assignment #2
RGA6207 Electronic Common TechnicalDocument (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
Are you busy and do not have time to handle your assignment? Are you scared that your paper will not make the grade? Do you have responsibilities that may hinder you from turning in your assignment on time? Are you tired and can barely handle your assignment? Are your grades inconsistent?
Whichever your reason may is, it is valid! You can get professional academic help from our service at affordable rates. We have a team of professional academic writers who can handle all your assignments.
Our essay writers are graduates with diplomas, bachelor, masters, Ph.D., and doctorate degrees in various subjects. The minimum requirement to be an essay writer with our essay writing service is to have a college diploma. When assigning your order, we match the paper subject with the area of specialization of the writer.
PLACE THIS ORDER OR A SIMILAR ORDER WITH USA ELITE WRITERS TODAY AND GET AN AMAZING DISCOUNT