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Question 1 List at least 6 post drug approval activities of FDA. Write brief ona) Medwatchb) AERSc) Pharmaceutical Industry surveillance
Question 2 Write a note on the followinga) Hale Amendmentb) Low-Acid Canned Food Regulation
Question 3 What are the responsibilities of CBER? How vaccines and blood products are regulated by CBER?
Question 4 What is ICH? List the 3 nations that form the steering committee of the ICH. Mention the salient features of the Nuremberg code, Belmont Report and Helsinki declaration
Question 5 Define Adverse Event, Adverse Drug Reaction and Unexpected Adverse Event. Explain the reporting time frames in clinical safety data management?
Question 6 What do you understand by pre-clinical studies, and what are the objectives of pre-clinical studies? What are the aspects that pre-clinical safety testing should take into consideration?
1.how to draw a stock control card and discuss the completion process . 2.Discuss the layout of the work space, to prevent accidents and injuries. 3.Explain the difference in level
The Code of ethics for Public Officers sets out the standards of correct conduct expected of Public Officers. It emphasizes the importance of a responsible, responsive and caring
What is the Always Better Control Analysis of Inventory Control? ABC Analysis of Inventory Control: Always Better Control Analysis of Inventory Control analysis is the ex
explain value creation and delivery in entrepreneur
QUESTION (a) Using suitable instances distinguish between formal and informal organization. (b) Describe any two characteristics of a formal organization. (c) Illustrate
On the 10 th of March 2009 Moot enterprise Ltd posted an offer to sell 1,000 set of encyclopedias to the Ministry of Education for the price of Rs 1,000,000 and that the offer wou
Modeling and simulation mean using models, prototypes, attributes, and strategies in order to get results that help to choose the right decision. Recently, simulation becomes a maj
Consider you are a consultant from the company Engineering Experts. One of your clients has contacted you to re-engineer the core process of his company. Explain how you will imple
Question 1: (a) List three types of supervision styles. (b) Describe each of them, stressing upon their importance to you as supervisors. (c) Write short notes on two maj
The phase consists of the followings activates: 1. Identify the core high level processes, 2. Recognize potential change enablers, 3. Gather performance metric withi
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