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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?
Problem 1 a) What do you meant by cultural context? b) Differentiate between low-context cultures and high-context cultures. c) How will we improve intercultural commu
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How is the matrix organisation created? Matrix organization is created through merging (as two complementary structures, as like) pure project organization and also functional
QUESTION Explain to the management of UTM Ltd the advantages and implications of using databases as opposed to using traditional flat file systems or spreadsheet files within t
The table below lists the seven wastes as the target for continuous improvement production process. 1. Waste of Overproduction : eliminate by reducing setup times synchronizing qu
QUESTION The Importance of Effective Communication The Building Societies Association (BSA) is the trade association for all the UK's building societies. A building societ
Question 1 Communication skills are of utmost importance in managing information and technology in any organization. List the characteristics of communication and discuss the seve
Ask questiWhat steps can Twelve Trees take to ensure that the agreement they have with Defang Hezuo''She continues to be profitable and stable well into the future?on #Minimum 100
What is the system concept of organisation? Explain briefly. System concept of Organisation: 1. System is a group of independent although inter dependent tools (called
Internal Integration - organizational culture Culture helps members develop a collective identity and know how to work together effectively. It is culture that guides day-to-d
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