RGA 6207 NEU BAXDELA Electronic Common Technical Document Essay
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 […]
RGA 6207 Reverse Translation Baxdela Writing Project
In completing Writing Assignment #1 for RGA6207 students will have the opportunity to “reverse translate” an FDA approved product insert and other documentation associated with approval of a pharmaceutical or biologic product back to the information submitted by the manufacturer in Module 1 of an eCTD submission. As discussed during Week 3 of the course, […]
RGA 6463 Northeastern University Regulatory Strategy & Product Development Case Study
DescriptionAs mentioned with the first two assigned cases key student learningoutcome(s)for the course includedemonstrating an understanding of compliance standards required to formulateregulatory strategies to supporteffective life–cycle management.Intellectual property strategy is a critical area of product life–cycle management in healthcare, as well as many other sectors of the global economy, but is often overlooked for a […]
