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Posted By: srinivas Member Level: Gold Posted Date: 30 May 2008
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2008 Andhra Pradesh State Jawaharlal Nehru Technological University Biotechnology III B.Tech II Semester Regular Examinations, Apr/May 2008 REGULATORY AFFAIRS AND CLINICAL TRIALS Question paper
Code No: R05322306 Set No. 3
III B.Tech II Semester Regular Examinations, Apr/May 2008
REGULATORY AFFAIRS AND CLINICAL TRIALS
(Bio-Technology)
Time: 3 hours Max Marks: 80
Answer any FIVE Questions
All Questions carry equal marks
1. Write the significance of clinical trials in biomedical research. [16]
2. Write about the obligations of investigators to obtain informed consent. [16]
3. Write about different types or Audit findings and explain follow-up GCP audit
reports. [16]
4. What are the legal sanctions the sponsor will face in case of non-compliance of EU
directives on GCP for clinical trials? [16]
5. Explain Auditing of Investigation Drug. [16]
6. Principles based on International Conference on Harmonization GCP guidelines.
[16]
7. Procedures for submission of supplement to an approved application. [16]
8. Write short notes on
(a) WHO
(b) FDA. [8+8]
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