JAWAHARLAL NEHRU TECHNOLOGICAL UNIVERSITY HYDERABAD
JAWAHARLAL NEHRU TECHNOLOGICAL UNIVERSITY HYDERABAD B.Pharmacy IV PHARMACOVIGILANCE Previous Question Paper (July - 2023 - R17)
Note: i) Question paper consists of Part A, Part B. ii) Part A is compulsory, which carries 25 marks. In Part A, answer all questions. iii) In Part B, Answer any one question from each unit. Each question carries 10 marks and may have a, b as sub questions.
Part A
Differentiate between type A and type B adverse drug reactions.
Answer
Type A reactions (Augmented) are dose-dependent, predictable, and related to the pharmacological action of the drug. Type B reactions (Bizarre) are dose-independent, unpredictable, and unrelated to the pharmacological action, often involving idiosyncratic or immunological mechanisms.
Write a short note on thalidomide tragedy.
Answer
The Thalidomide tragedy occurred in the late 1950s and early 1960s when the drug, used as a sedative and anti-emetic for pregnant women, caused severe birth defects, specifically phocomelia (malformed limbs). This event acted as a global catalyst for the development of modern pharmacovigilance systems and more stringent drug regulation.
What do you mean by ATC? Write its significance.
Answer
Sign in to view the complete answer paper.
Write a short note on establishment of ADR monitoring center in hospital.
Answer
Sign in to view the complete answer paper.
Write about Stimulated reporting in pharmacovigilance.
Answer
Sign in to view the complete answer paper.
What are Adverse events following immunization?
Answer
Sign in to view the complete answer paper.
Define ICSRs.
Answer
Sign in to view the complete answer paper.
Write the objectives of ICH.
Answer
Sign in to view the complete answer paper.
Differentiate between Pediatrics and Geriatrics.
Answer
Sign in to view the complete answer paper.
Write a short note on Drug safety evaluation.
Answer
Sign in to view the complete answer paper.
Part B
Describe the methods in Causality assessment.
Answer
Sign in to view the complete answer paper.
Write in detail about reporting and analysis of ADRs.
Answer
Sign in to view the complete answer paper.
Write the role of medical coding in Pharmacovigilance.
Answer
Sign in to view the complete answer paper.
Differentiate between serious and non-serious ADRs. Why pharmacovigilance needed? Explain with suitable examples.
Answer
Sign in to view the complete answer paper.
Write in detail about establishment and operation of drug safety department in industry.
Answer
Sign in to view the complete answer paper.
Write the procedure to set up AMC in India.
Answer
Sign in to view the complete answer paper.
Write the procedure to set up pharmacovigilance center in CROs.
Answer
Sign in to view the complete answer paper.
Define adverse events following immunization. Explain in detail about AEFI.
Answer
Sign in to view the complete answer paper.
Explain the role of active surveillance in pharmacovigilance.
Answer
Sign in to view the complete answer paper.
Write about Vaccine safety surveillance program of India.
Answer
Sign in to view the complete answer paper.
Define signal. Write about different types of methods involved in signal detection.
Answer
Sign in to view the complete answer paper.
Explain about Good clinical practice in pharmacovigilance studies.
Answer
Sign in to view the complete answer paper.
Describe about Post approval expedited reporting as per ICH guidelines.
Answer
Sign in to view the complete answer paper.
Explain about drug safety evaluation in Pediatrics.
Answer
Sign in to view the complete answer paper.
Explain about drug safety evaluation in Geriatrics.
Answer
Sign in to view the complete answer paper.