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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 The best indicator of behaviour is intention. a) Describe the theory you would use to explain the above and explain the importance of this theory. b) Elaborate
Most air travelers now use e-tickets. Electronic ticketing permits passengers to not worry about a paper ticket, and it costs the airline companies less to handle than paper ticket
Discuss how organisational commitment encourages knowledge sharing.
Another important decision is maintaining inventory and determining the inventory level. An inventory level is a quantitative limit, which should neither be much higher nor
Question: (a) You have been appointed as the Human Resource Manager of BPO Ltd and the Chief Executive Officer has requested you to propose measures to improve industrial relat
How is the market mix illustrated by the P variables of marketing? The given figure demonstrates the market mix, additionally sub divided as: The marketing mix is the centra
Ask question #Minimum 100 words accePhase 1: (5%)pted#
Question 1: (a) Define the concept of ‘organisation' and ‘organisational behavior' (b) Discuss the importance of job satisfaction in organisations. Question 2: (a) D
a) Talk about the significance of international trade to UK business organisations b) Examine the impact of global factors on UK business organisations c) Detail the impac
From your past investment portfolio strategy and your explanation to your client, outline the basis of your future portfolio for the same principal and indicate the rationale for y
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