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

Cultural context, Problem 1 a) What do you meant by cultural context? ...

Problem 1 a) What do you meant by cultural context? b) Differentiate between low-context cultures and high-context cultures. c) How will we improve intercultural commu

How is the matrix organisation created, How is the matrix organisation crea...

How is the matrix organisation created? Matrix organization is created through merging (as two complementary structures, as like) pure project organization and also functional

Advantages and implications using databases, QUESTION Explain to the ma...

QUESTION Explain to the management of UTM Ltd the advantages and implications of using databases as opposed to using traditional flat file systems or spreadsheet files within t

Improvement production process, The table below lists the seven wastes as t...

The table below lists the seven wastes as the target for continuous improvement production process. 1. Waste of Overproduction : eliminate by reducing setup times synchronizing qu

The importance of effective communication, QUESTION The Importance of ...

QUESTION The Importance of Effective Communication The Building Societies Association (BSA) is the trade association for all the UK's building societies. A building societ

Written messages must be as readable as possible, Question 1 Communication...

Question 1 Communication skills are of utmost importance in managing information and technology in any organization. List the characteristics of communication and discuss the seve

Twelve trees, Ask questiWhat steps can Twelve Trees take to ensure that the...

Ask questiWhat steps can Twelve Trees take to ensure that the agreement they have with Defang Hezuo''She continues to be profitable and stable well into the future?on #Minimum 100

What is the system concept of organisation, What is the system concept of o...

What is the system concept of organisation? Explain briefly. System concept of Organisation: 1.  System is a group of independent although inter dependent tools (called

Internal integration - organizational culture, Internal Integration - organ...

Internal Integration - organizational culture Culture helps members develop a collective identity and know how to work together effectively. It is culture that guides day-to-d

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