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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?
Managing diversity is about more than equal employment opportunity and affirmative action (Losyk, 1996). The organisation should create such a working environment as will increase
Probelm 1: Show the official roles of the chairperson, the secretary and members before, during and after formal meetings. Probelm 2: Consider that you are the team lea
Objective of Maintenance Management 1. Minimizing the loss of productive time because of equipment failure i, e, minimizing idle time of equipment due to break down) 2.
Approaches to short-term financing problem?
What are the important provisions for employee employment of young person? The provisions for employment of young person are as below: a. Prohibition of employ of young chil
Hazards and Risks at BMW
Explain why the composition of the working capital of a business is as important as the value of that working capital.
P&L for Masks R Us Ltd: a) $ $ Sales ($8 * 15,000) 120,000 Cost of Goods Sold :
describe the all points of organization process.
explain concept of culture as learned behaviour
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