Write a short, 1-2 page (or 4-6 paragraph) essay for each question you choose. You should use the questions in bullet points as orientation on how to structure your answer.

Question 1:

Bust no more about the subtle Greek / Or the long odyssey of Trojan Aeneas; / Enough of the oriental conquests / Of great Alexander and of Trajan; / I sing of the famous Portuguese / To whom both Mars and Neptune bowed. / Abandon all the ancient Muse revered, / A loftier code of honour has appeared.
(Luis de Cames, The Lusiads, I, 3)

How does Cames characterize his poem in this quotation?
What does he mean by a loftier code of honour, and in relation to which previous one?
And how do these verses fit into The Lusiads

Question 2:

As to their miscibility, no colonizing people in modern times has exceeded or so much as equated the Portuguese in this regard. From their first contact with women of color, they mingled with them and procreated mestizo sons; and the result was that a few thousand daring males succeeded in establishing themselves firmly in possession of a vast territory and were able to compete with great and numerous peoples in the extension of their colonial domain and in the efficiency of their colonizing activity. Miscibility rather than mobility was the process by which the Portuguese made up for their deficiency in human mass or volume in the large-scale colonization of extensive areas. For this they had been prepared by the intimate terms of social and sexual intercourse on which they had lived with the colored races that had invaded their peninsula or were close neighbors to it, one of which, of the Mohammedan faith, was technically more highly skilled and possessed an intellectual and artistic culture superior to that of the blond Christians.
(Gilberto Freyre, The Masters and the Slaves, 1933)

What does Freyre mean by “miscibility”?
What do you think of this idea and why may it be problematic as well as productive in thinking about the making of Brazilian society?
How does this passage relate to the argument of The Masters and the Slaves more generally, and in what ways could it have buttressed ideological justifications for Portuguese colonialism?

In completing Writing Assignment #3 for RGA6207 students will have the opportunity to:
• Demonstrate an understanding of the importance of choosing eCTD software to assist in eCTD
submissions
• Demonstrate an ability to interpret a publicly available information about different eCTD
software solutions
• Demonstrate an ability to apply information presented in RGA6207 regarding eCTD submissions
and best practices to a real-world scenario
For this assignment, you are a Sr Manager of Regulatory Affairs at a small, emerging biotechnology
company that has completed all aspects of development for a combination drug/device product called
CVT-301. CVT-301 was developed for treatment of the symptoms of Parkinson’s Disease. It is now time
for you to select an appropriate eCTD software tool (or tools) to best assist you in an eCTD-compliant
submission of your company’s first NDA.
As the Sr Manager of Regulatory Affairs, it is your task to:

1. Describe the basics of NDA submission best practices
2. Describe the reasons for why eCTD software is needed to help in the submissions process,
   including details of HOW the software program (or programs) can help
3. List 3 to 5 eCTD software products on the market and briefly describe their capabilities (Is this
   software that helps with conversion of word documents to eCTD-compliant PDFs? Is this
   software that organizes the eCTD documents into their appropriate hierarchy/granularity?)

Sample Solution

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