What are the responsibilities of cber, Business Management

Assignment Help:

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?


Related Discussions:- What are the responsibilities of cber

Managing diversity - combating challenges, Managing diversity is about more...

Managing diversity is about more than equal employment opportunity and affirmative action (Losyk, 1996). The organisation should create such a working environment as will increase

Describe the difficulties that you may encounter, Probelm 1: Show the o...

Probelm 1: Show the official roles of the chairperson, the secretary and members before, during and after formal meetings. Probelm 2: Consider that you are the team lea

Objective of maintenance management, Objective of Maintenance Management ...

Objective of Maintenance Management 1. Minimizing the loss of productive time because of equipment failure i, e, minimizing idle time of equipment due to break down) 2.

Business finance, Approaches to short-term financing problem?

Approaches to short-term financing problem?

Important provisions for employee employment of young person, What are the ...

What are the important provisions for employee employment of young person? The provisions for employment of young person are as below: a. Prohibition of employ of young chil

ORKING CAPITAL, Explain why the composition of the working capital of a bus...

Explain why the composition of the working capital of a business is as important as the value of that working capital.

P&l for masks r us ltd, P&L for Masks R Us Ltd: a)   ...

P&L for Masks R Us Ltd: a)   $ $ Sales ($8 * 15,000)   120,000 Cost of Goods Sold :

Organization, describe the all points of organization process.

describe the all points of organization process.

Write Your Message!

Captcha
Free Assignment Quote

Assured A++ Grade

Get guaranteed satisfaction & time on delivery in every assignment order you paid with us! We ensure premium quality solution document along with free turntin report!

All rights reserved! Copyrights ©2019-2020 ExpertsMind IT Educational Pvt Ltd