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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?
Row Minima Methods: Steps1: The smallest cost in the first row of the transportation table is determined. Let it be C 1j . allocate as much as possible amount X 1j
Discuss De-cruitment in the context of the Break-Even model
Question: (a) What is the relevance of an Initial Public Offering (IPO) for an Internet startup? (b) Consider the following extract from Google's IPO filing document
Select a company of your choice. You are to analyse, evaluate and critique the company's approach to Innovation Management. Identify who the key player/s is/are? Comment on the ty
Problem 1. How do you and your organization define system? Mention the systems that require engineering. Defining system Mentioning the systems that require engineerin
What strategies might be used in gaining acceptance for an OD program
b. A paper mill produces two grades of paper viz., X and Y. Because of raw material restrictions, it cannot produce more than 400 tons of grade X paper and 300 tons of grade Y pape
breifly describe the following models of human resource management; 1the guest model of hrm 2the michigan matching model of hrm 2the harvard model of hrm 3the john storey model of
The aim of the assignments is to test your understanding of some of the key concepts in the material covered in the study modules, examine your ability to critically analyse a part
QUESTION (a) Compare the two- and three-tier Web client-server architectures, and indicate the role of each tier in each architecture. Which architecture is the most likely can
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