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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?
"Only projects with a positive NPV should be considered and projects with a negative NPV should be discarded". Briefly discuss this statement. Define what is meant by 'Value A
Primary activities of a Hotel in value chain analysis.How a big hotel performs them?
if can make in 6 hours Personal Business Plan . The plan should have the following elements: Executive Summary Products and Services Market Analysis Summary - Ma
explain the recruitment and selection process
Discovering Accident Causes: Before any steps can be taken in it is essential to find out: The causes of previous accidents and The existing hazards that may causes
There is always variation in demand and supply of product. The protection against such unpredictable variations can be done by means of buffer stocks. a. Changes
Determine the sample size needed to cut the Margin of Error: Below you are given ages that were obtained by taking a random sample of 9 undergraduate students. 19 22 23 19
Question 1: "Training is usually treated as a cost in many organizations rather than an investment since in difficult times, many organizations cut their training budget first
What is break-even point? Break-even point: Break-even point is the volume of output at that neither a loss is incurred nor a profit is created. The break even analysis c
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