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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?
Define Channel System
For question10 on page 198 of your text. Perform a SWOT analysis on NCC. Provide lists for NCC''s Strengths, Weaknesses, Opportunities, and Threats. Use pages 190-192 as a guide,
Discuss about the policy and operative managerial decisions. Policy and Operative decisions: Policy decisions are very significant, they are occupied by top management, a
Heath & Safety in the Workplace 1) There are 5 primary steps in assessing risk in the workplace wrt to H&S, identify 3 and discuss the what actions should be taken to manage or
A detailed costing of the capital equipment based on individual costing for each unit operation and associated equipment. This cost should be cross-checked against costs estimated
Electronic marketing (E-marketing) can be viewed as a new modern business practice associated with buying and selling goods, services, information and ideas via the Internet and ot
QUESTION (a) In the banker-customer contractual relationship, each party has some rights and duties. Describe the rights and duties of both the banker and the customer, quoting
The LD2 group has grown rapidly over the past five years by acquiring a number of smaller kitchen accessory manufacturers and kitchen suppliers and fitters. As a consequence of thi
For proper inventory control standardization of materials and products as well as simplification of the production line is necessary standardization refers to limiting o
QUESTION 1 (a) Describe the process of growth and development of individuals over the whole life span, highlighting the various milestones (b) Which period would you conside
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