great results for another. The FDA has twelve stages of drug development and Review; these are important procedures before and after clinical trials. The twelve stages of drug development fall into the FDA’s four categories: pre-clinical, clinical, NDA (New Drug Application) review and post marketing. In the pre-clinical category there are two stages; animals tested and IND (Investigational New Drug) Application. The drug sponsor, companies/research institutions responsible for developing
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Assignment Answer QUESTIONS NDAS Case Study – PART 1 Read the following case study and answer the following questions. 1. Briefly describe the current state of NDAS’s office automation, system integration, and networking. Begin by explaining how each department uses information technology, what hardware it uses, and what functions currently are automated. Also assess which department is most in need of a network. [5 marks] The level of automation varies significantly among the NDAS departments and offices
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Order Code RS22814 February 21, 2008 FDA Fast Track and Priority Review Programs Susan Thaul Specialist in Drug Safety and Effectiveness Domestic Social Policy Division Summary By statutory requirements and by regulation, guidance, and practice, the Food and Drug Administration (FDA) works with several overlapping yet distinct programs to get to market quickly new drug and biological products that address unmet needs. FDA most frequently uses three mechanisms for that purpose: Accelerated
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1. Evaluate the situation in which Mason and Shepherd find themselves with respect to their existing employers. What legal and ethical issues do you see and how would you advise them to proceed? Mason's endeavor for the venture creation is strictly bounded by her employment agreement with ATS. That is to say, she will be in clear violation of the Noncompetition, Nonsolicitation, Nondisclosure and Development provisions, if she plans to pursue the venture within one year by utilizing the
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integration, and networking. Begin by explaining how each department uses information technology, what hardware it uses, and what functions currently are automated. Also assess which department is most in need of a network. NDAS was established in 1985. The main objective with NDAS is to compete in todays growing market for overnight package deliveries. The current state of automation varies among departments. Computers are linked to a LAN that only attends for Sales and Marketing. The Accounts Receivable
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Chapter 1 – Introduction to Data Communications Th is is th e b egin n in g of a cu m u la tive ca s e s tu d y a b ou t a fictit iou s fir m we ca ll Next-Da y Air S er vice (NDAS ). Th e ca s e s t u d y b egin s h er e in Ch a p ter 1 a n d con tin u es th r ou gh ou t th e r es t of th e b ook . It r equ ir es you to com p lete ta s k s th a t a r e r ela ted to top ics cover ed in ea ch cor r es p on d in g ch a p ter of th e text. Th e en d of ea ch ch a p ter con ta in s th e ca s e n a r
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Pre-course Assignment – NDAS Case Study Question 1 The current level of office automation at NDAS varies with each department. The company is also in the process of upgrading its computer systems to improve performance and reduce costs. The Payroll Department has a minicomputer on which it runs the payroll twice monthly. The Sales and Marketing department has a desktop computer for each account representative. All the computers are connected to a LAN, which serves only the Sales and Marketing
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INTELLECTUAL PROPERTY RIGHTS What is an Intellectual Property? With compared to real property, Intellectual Property is NOT tangible because it is not a product of human skill but of human intellect. Therefore it is said that “it is a fruit of human intellect”. Why Intellectual Property Rights are important? Although it is a fact that the power of thinking or the Power of mind cannot be stolen by a powerful third party, it is equally true that “ Intellectual Property Rights
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Chapter 1 – Introduction to Data Communications Th is is th e b egin n in g of a cu m u la tive ca s e s tu d y a b ou t a fictit iou s fir m we ca ll Next-Da y Air S er vice (NDAS ). Th e ca s e s t u d y b egin s h er e in Ch a p ter 1 a n d con tin u es th r ou gh ou t th e r es t of th e b ook . It r equ ir es you to com p lete ta s k s th a t a r e r ela ted to top ics cover ed in ea ch cor r es p on d in g ch a p ter of th e text. Th e en d of ea ch ch a p ter con ta in s th e ca s e n a r
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Trade secret In regards of Schlossberger’s suggestion that the duty to respect trade secrets has limit and is overridden, it seem more emphasizing in whistle blowing aspect. So the question rises that under what conditions is whistle blowing moral justified? In my opinion, it does not matter what one’s obligations or confidentiality agreements, one is never exempt from the general obligations we have to our fellow human beings. One of the most fundamental of these obligations is not to cause harm
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