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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?
Question 1: "Planning, organising and controlling are the key functions of management." Discuss Question 2: Analyse the variety of skills that managers must display to
Question 1: (a) Describe the two main criteria that have contributed to intercultural communication within the work environment. (b) Clearly show three challenges and t
Ask question #Minimum 100 words accePhase 1: (5%)pted#
Question 1: (a) Using relevant examples distinguish clearly between public and private welfare institutions stressing the basic difference in their overall administration.
QUESTION Because non-verbal cues can mean more than spoken words and speak louder than spoken words, mastering non-verbal communication skills at work represents a challenge (G
List and explain the seven steps in developing a global outsourcing strategy. Seven steps in developing a global outsourcing strategy - Segment the marketplace, Project change
is bureaucratic approach appropriate for nestle
Management is Really useful for decesion making if your statement is true then comment !how?
Nature of Business Activity a) The fashion magazine is probable to contain text and coloured photos which bring in outlying greater value to the consumer than 100 pages of pap
Understand the concept of leadership and management, and demonstrate sound knowledge and understanding of the concepts, theories and disciplines which underpin business and managem
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