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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?
Demonstrates the skill at different levels of management? Require for a skill at various levels of Management is demonstrated below into the diagram as demonstrated below:
This is innovative approach of maintenance developed by Japanese manufacturers for their plants and machinery. In this concept the principle of all the above there method
#question;how to write a research problem in a clearly research language?
The Williams & Wiley partnership has two partners and each partner has $50,000 invested in the firm. Woods is admitted to the partnership for one-third interest and invests $80,000
Where are the training and education different? The training and education are different from that of given level within content and method. 1. Work Force. 2. Middle Leve
Q. Conflicts in Profit versus Value Maximization Principle? 1) Conflict between Departmental Goal and Firm Goal: There are several departments in affirm such as sales departmen
Competitive Environment and Strength of a Company Over the years the growth in Glass industry had slowed down and margins are shrinking in high volume markets. The reason attr
VK Ltd a multi product company, furnishes you the following data relating to the year 2000. First half sales Second half sales Sales Rs.45000 Rs.50000 Total cost Rs.40000 Rs.43000
1. Business Continuity is based on disaster recovery. Discuss this statement highlighting the technology and processes involved. 2. A large online bank is considering implementi
QUESTION An information system should provide good and valuable information to its users. (a) How would you distinguish data and information? (b) Write short notes on any
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