grading criteria: Essays will be graded largely on the following criteria: clarity of expression; responsiveness to the essay prompt (in substance and form); data/references provided in support of assertions made; use of language appropriate for the academic environment.

Each essay/paper should be 1-page in length (single-spaced, 12pt. Times New Roman), and be submitted in PDF or MS-Word format. Your discussion should be written in your own words. Plagiarism is strictly prohibited. If you include language (even if rearranged or modified) from another source, then the source should be cited (and as appropriate, language should be enclosed in quotes). Essays submitted must be originally written this semester, for this class. You may not repurpose work from other classes, even if authentically authored by you.

Please be sure to submit your essay assignment on time. It would be wise to plan to submit your HW assignments at least several days before the due date, in order to eliminate the risk of a hiccup. Because you have ample advance time during which to submit your essay, it will be entirely your responsibility to do so, and late HW assignments will not be excused (even with most verifiable excuses).

ASSIGNMENT: “Tomorrow’s challenges”

Preface: In the real world, as business professionals and citizens, it is good to think about, and to contribute to, these conversations, particularly as influential people in your relative arenas in which you will be heard, and be able to help shape our future.

Assignment: Find a topical/frontier subject, perhaps of particular personal interest or from news headlines, on a technological or other frontier, for which one might be led to ask questions about whether existing laws might adequately address these evolving technologies or conditions. Some topic examples might include (but are certainly not limited to): new environmental changes/challenges, virtual-reality technology, artificial-intelligence, genetic-planning, space-exploration and its implications. These are just a few examples. Take any “frontier” subject, and ask critical questions about how we, as a society, may want to address previously unforeseen issues, and explore possible new legislation to address them. You do not need to do extensive research on these topics (though you should do at least some basic google searching). A primary point of this exercise is to raise questions about the subject, and to use your imagination to think creatively, hypothetically, and critically about what new legal challenges/conflicts these developments could present.

Metropolitan Edison Company owned and operated two nuclear-fueled power plants at Three Mile Island near Harrisburg, Pennsylvania. Both power plants were licensed by the NRC after extensive proceedings and investigations, including the preparation of the required environmental impact statements. When one of the power plants was shut down for refueling, the other plant suffered a serious accident that damaged the reactor. The governor of Pennsylvania recommended an evacuation of all pregnant women and small children, and many area residents did not leave their homes for several days. As it turned out, no dangerous radiation was released.

People Against Nuclear Energy (PANE), an association of area residents who opposed further operation of the nuclear power plants at Three Mile Island, sued to enjoin the plants from reopening. They argued that the reopening of the plants would cause severe psychological health damage to persons living in the vicinity and serious damage to the stability and cohesiveness of the community. Are these reasons sufficient to prevent the reopening of the nuclear power plants? Is it socially responsible for the federal government to permit the operation of nuclear power plants? Metropolitan Edison Company v. People Against Nuclear Energy, 460 U.S. 766, 103 S.Ct. 1556, 1983 U.S. Lexis 21 (Supreme Court of the United States)

Please follow the instruction and examples

Read the NBC News article “Cleveland Shooting Highlights Facebook’s Responsibility in Policing Depraved Videos.”Then write a 2–3 page paper that considers the following:

1. Discuss whether you believe that Facebook has a legal or ethical duty as to what gets posted on its platform. If someone is recorded and viewed getting hurt, is Facebook legally liable to the victim? Why or why not?
2. Research and suggest three ways that social media platforms such as Facebook can be more proactive and thorough in reviewing the conduct and content of what appears on their sites, and in preventing acts of violence. Support your answer.
3. Determine whether Facebook can be sued for invasion of privacy if one’s personal information, likes, dislikes, and photos are shared with product and advertising agencies.
4. Propose two changes Facebook should adopt to encourage the ethical use of its platform.

Use the Strayer Library to conduct your research. Include at least two quality references. Note: Wikipedia and similar websites do not count as quality references.Your assignment must follow these formatting requirements:

• This course requires the use of Strayer Writing Standards. For assistance and information, please refer to the Strayer Writing Standards link in the left-hand menu of your course.
• Typed, double-spaced, using Times New Roman font (size 12), with 1-inch margins on all sides.
• Include a cover page containing the title of the assignment, the student’s name, the professor’s name, the course title, and the date. The cover page and the reference page are not included in the required assignment page length.

• You have three questions. Each question is separated from the others. So, you have to deal with each question separately and do not join between the data mentioned in each.
• The maximum limit for the answer of each question is one page.

I uploaded the questions and the all the information or terms you can use.

In completing Writing Assignment #1 students will have the opportunity to:

• Demonstrate understanding of the history and impacts of the ICH’s development of eCTD

• Describe the founding regions of the ICH as well as the makeup of the ICH membership with respect to agencies and observers

• Demonstrate knowledge of the basic structure of the eCTD

• Demonstrate an understanding of the basic aspects of the role of regulatory affairs in the eCTD submission process

For this assignment, you are a Sr Manager of Regulatory Affairs at a small, emerging biotechnology company called Silencia Therapeutics. The year is 2018 and you and your colleagues at Silencia Therapeutics are planning to submit your company’s first Investigational New Drug (IND) application to the FDA in order to enable the start of your first in human phase 1 clinical trial. Silencia is a small company of only 15 employees and you are the only regulatory affairs professional in its employ. Additionally, your IND submission is targeted for August 2018, just 4 months after the FDA’s mandatory cutoff for all IND applications to be made electronically in the CTD format. As Silencia is a small company, most of its employees are new to the clinical phases of drug development and have never submitted an IND to FDA and are completely unaware of what the CTD is or how electronic CTD submissions are made. As the Sr Manager of Regulatory Affairs, it is your task to develop an Executive Brief that you will deliver to your peers and also the Chief officers (including CEO!) of the company.

Your executive brief needs to be 5 – 7 pages 12- or 11-point font, double spaced and needs to include, at a minimum, a review of the following information:

• An introduction to ICH, its history, and its current membership. What countries formed the ICH? Are regulators and industry professionals able to join?

• An overview of the rationale for the ICH’s development of the electronic CTD. What is the eCTD and why has ICH developed this document?

• An in-depth review of the benefits of eCTD. How does eCTD help to improve the drug development process?