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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?
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
Inspection of production takes time which may extend from a few hours to a number of days depending upon the nature of the product. It is necessary to exercise suitable o
You have been appointed as part of a consultancy team that has been commissioned to assess the management issues concerned with the delivery of an online system for the submission
Ques.1 Comment on “Quantitative Techniques is a scientific and for enhancing creative and judicious capabilities of a decision maker”, also state the different elements of Decision
Which parties have a basic obligation in collective bargaining? In collective Bargaining the parties, which are management representatives and also union officials both have a
Calculate the cash discount and the net amount due for the following transaction. Amount of Invoice Terms of Sale Cash Discount Net Amount Due $12,660.00 2/10, n/45
I''m kindly asking to make an assignment against "Marketing Plan in employee performance Strategic" in 2000 words as per first attachment, also I need a Report against the assignme
Question 1: (A) Differentiate between work group and work team. (B) Fully explain the four types of teams. Question 2: State the factors associated wi
"Society can survive only if there exists among its members a sufficient degree of homogeneity; education perpetuates and reinforces this homogeneity by fixing in the child from th
What are the types of different barriers to successful communication? Various barriers to successful communication are as illustrated here: a. More levels within the organis
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