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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?
Question 1: (a) How does organisational culture develop? (b) What are the functions of an organisational culture? (c) What are its drawbacks? Question 2: (a) What are t
micro and macro environment assignment example
QUESTION Instruction: Read the following case study and answer the questions below Jane, a new woman manager has joined XYZ company. Jill, an employee was only working fo
Examine this business leader's leadership style and talk about how he or she has adapted to cultural differences and how he or she operates the business effectively in global marke
Question 1: Describe the concept of Cognitive Dissonance theory. What are the strategic core values of Quality Management System (QMS)? Concept of Cognitive Dissonance th
It is characterized by the number of manufacturing stages and the inter relationship between various production operations e, g, in product line systems inventory con
QUESTION 1 (a) Explain the importance of communication at work (b) Identify some major barriers to communication at work QUESTION 2 Explain how information technolog
Difference between selling concept & marketing conceptt
After several discussions and meetings with the technical directors we identified the following constraint: Budget The time frame /Completion of the project is a c
Draw a Context Diagram and a Level 0 Diagram using Visio for the following system : The pharmacy at Mercy Hospital fills medical prescriptions for all hospital patients and di
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