Download GTU B.Pharma 2019 Winter 7th Sem 2270010 Pharmacovigilance Question Paper

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Seat No.: Enrolment No.

GUJARAT TECHNOLOGICAL UNIVERSITY

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Instructions:

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1. Attempt any five questions.
2. Make suitable assumptions wherever necessary.
3. Figures to the right indicate full marks.

Q.1

1. Discuss forms and formats of SRS. (06)

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2. Define Signal. Discuss sources and scope of signal detection. (05)
3. Discuss potential and limitation of SRS. (05)

Q.2

1. Define : substandard/spurious/falsely labelled/falsified/counterfeit (SSFFC) medicines. (06)
2. Explain Pattern and scale of counterfeiting. (05)

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3. Write methods of detection of medication errors. (05)

Q.3

1. Explain current methods of Pharmacovigilance. (06)
2. Write a note on Pharmacovigilance in clinical trial. (05)
3. Write a note on Pharmacovigilance regulation in india. (05)

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Q.4

1. Write role of ICSRs in pharmacovigilance. (06)
2. Write a note on observational studies. (05)
3. Describe structure, validity and assessment of ICSRs in Pharmacovigilance. (05)

Q.5

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1. Define ADRs. Explain the types of ADRs with suitable examples. (06)
2. Write role of pharmacist in the management of adverse drug reactions. (05)
3. Differentiate between Adverse drug reaction and Adverse event. (05)

Q.6

1. What are merits and demerits of spontaneous reporting? (06)

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2. Write a note on adverse drug reactions of Liver. (05)
3. Write a note on Dermatological ADRs. (05)

Q.7

1. Write a note on naranjo’s causality assessment scale. (06)
2. Explain spontaneous reporting of adverse drug reactions with suitable examples. (05)

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3. Write mechanism of ADRs with examples. (05)

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