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

A source perspective and a receiver perspective, QUESTION 1 The best in...

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

normality assumption , Most air travelers now use e-tickets. Electronic ti...

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

Managing Knowledge, Discuss how organisational commitment encourages knowle...

Discuss how organisational commitment encourages knowledge sharing.

Determining various stock levels, Another important decision is maintaini...

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

Improve industrial relations in the company, Question: (a) You have bee...

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 market mix illustrated by p variables of marketing, How is the marke...

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

Ethics, Ask question #Minimum 100 words accePhase 1: (5%)pted#

Ask question #Minimum 100 words accePhase 1: (5%)pted#

Discuss the importance of job satisfaction in organisations, Question 1: ...

Question 1: (a) Define the concept of ‘organisation' and ‘organisational behavior' (b) Discuss the importance of job satisfaction in organisations. Question 2: (a) D

european union , a)  Talk about the significance of international trade to...

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

Investment portfolio strategy, From your past investment portfolio strategy...

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

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