What are the responsibilities of cber, Business Management

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Question 1 List at least 6 post drug approval activities of FDA. Write brief on
a) Medwatch
b) AERS
c) Pharmaceutical Industry surveillance

Question 2 Write a note on the following
a) Hale Amendment
b) 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?


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