Legal Environment of Business Employee Privacy
I attached my assignment below.
Please send it by TODAY (July 30) at 5pm (Eastern Time Zone – USA)
Advantages of ICH in Drug Development
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?
Stress Reduction Plan
As the company HR representative, you have been tasked with presenting a plan to your manager that will help reduce stress in the workplace.
Address the following in a 10- to 15-slide presentation with speaker notes:
- Evaluate existing and potential stressors within the workplace.
- Develop a plan to help reduce employee stress in your given place of employment.
- Determine how you will evaluate your plan for effectiveness.
- Assess how the stress reduction plan will lead to overall performance improvements.
- Include a minimum of one reference.
Analysis of Business & Business Laws Paper & Technological Changes
I need a paper that is A+ quality, its not a difficult topic. I will attach the rubric will all the directions, however please bid on this question if you are knowledgeable with business law and the fundamentals of business. I have a general idea of the comapany I want to choose.
Eleventh Circuit Court of Appeals Discussion
In United States v. Hall, 47 F.3d 1091 (11th Cir. 1995), the Eleventh Circuit Court of Appeals discussed the difference between a business and an individual’s reasonable expectation of privacy in the area around their home or business (called the curtilage). In Hall, a government agent seized a bag of shredded documents from a dumpster located on the property of Bet-Air, Inc. Hall filed a motion to suppress the evidence on the grounds that the search and seizure was a violation of the Fourth Amendment. Review United States v. Hall and discuss the following:
- What was the Court of Appeal’s decision?
- Was the search and seizure a violation of the Fourth Amendment? Why or why not?
- Would the result have been different if the dumpster was on private property rather than on commercial property?
- Suppose you were an executive at Bet-Air. What recommendations would you make to help Bet-Air assert an expectation of privacy in the dumpster?
Your initial response should be a minimum of 500 words.
Negligence for Causing the Car Accident
Note: Study guide is attached
Case Analysis
Dave is a driver for Empire Courier Service. Around the company, Dave is known as sort of a hothead. During his previous employment at another company, Dave had been involved in a workplace fistfight with a fellow employee, resulting in criminal charges.
One day, between deliveries and in a company vehicle, Dave decides to get lunch. While leaving the parking lot at Big Burrito Bistro, the favorite lunch spot for most Empire Courier employees, Dave negligently causes a car accident with another vehicle, resulting in injuries to Victor, the driver of the other car. As Dave and Victor are waiting on the side of the road for the police to arrive, Victor comments to Dave, “Oh, you drive for Empire Courier Service. It doesn’t surprise me that Empire hires bad drivers because their service stinks, and their prices are too high!” Dave is so offended that Victor would insult his employer’s professional reputation that he punches Victor in the face, causing Victor to suffer even more injuries. Empire Courier Service does not, as a matter of policy, do criminal background checks on its employees.
Considering the legal principles discussed in Chapter 20, explain who is liable for Dave’s negligence for causing the car accident, and explain who is liable for Dave’s intentional tort for punching Victor. Provide your answers in a case analysis of a minimum of 500 words. Cite any direct quotes or paraphrased material from outside sources. Use APA format.
Insurable Interests Business and Personal Insurance Policies
- Define insurable interests, business, and personal insurance policies
You and a colleague are starting a new business. Your colleague knows everything about the product and service you are providing. You are experienced in business and administration. Your colleague tells you that she wants to handle the product and service quality and that you can handle all business matters.
She also tells you that this new business will require an office, warehouse space, delivery vehicles, machinery and other general items needed to operate an office and manufacturing warehouse. You will have about thirty employees.
She asks you what you plan regarding obtaining insurance coverage for the company. Describe the types of insurance coverage you feel are necessary to cover the business, its owners, and employees and explain why. For the purposes of this discussion, exclude any reference to health insurance coverage.
Implications of Quarantine on Contractual Obligations
we are to summarize how the current 19 has affected people in their contracts with businesses if they have or haven’t completed the signed duties. What makes a contact valid and what are the components of the constitution
Attachment preview
The US has been under coronavirus quarantine for some time now. Given that various contracts have been negotiated by parties to the contract, and some have performed on the agreed contract and others have not as agreed.
Business Law and Sale of Goods
at April 20 GMT-3 designed to take you 1.5 hour
15 short answer questions
The sample and review material were attached below.
Huawei Crisis and Intellectual Property
Hey buddy as i said all the response regarding the question is given. You have to make discussion and comment on each response. Make it like a conversation, ask questions, make your view points. Each should be around 200-250 words. Total 5 response you will have to make
WE accept
