B.Pharma Important Question
BP-803T(G)/BP-804T(B)
Pharmacovigilance,
VIII Sem, RGPV, B.Pharmacy
Unit-I Introduction to Pharmacovigilance
Q.1 Mention the methods in causality assessment. Explain Bayesian approaches. (RGPV May 2024)
Q.2 Discuss the role of the Pharmacovigilance Program of India. (RGPV May 2024)
Q.3 Give a detailed note on good clinical practice in pharmacovigilance studies. (RGPV May 2024)
Q.4 Enumerate the history and development of pharmacovigilance. (RGPV May 2024)
Q.5 Define and classify Adverse Drug Reaction (ADRs) with methods used for causality assessment of ADRs. (RGPV May 2022)
Q.6 Discuss in detail about methods of Causality Assessment. (RGPV May 2022)
Q.7 Discuss the management of Adverse drug reactions .Adverse drug reactions. (RGPV May 2022)
Q.8 Explain in detail about history and development of Pharmacovigilance with special reference to Pharmacovigilance Program of India (PvPI). (RGPV Jun 2020)
Q.9 Define and classify Adverse Drug Reaction (ADRs) with methods used for causality assessment of ADRs. (RGPV Jun 2020)
Unit- II Drug and Disease Classification
Q.1 What is MedDRA? Discuss its scope, structure and characteristics. (RGPV May 2024)
Q.2 Discuss the international classification of Diseases. (RGPV May 2022)
Q.3 Discuss in detail about Contract Research Organizations. (RGPV May 2022)
Q.4 Discuss WHO international drug monitoring programme. (RGPV May 2022)
Q.5 Enumerate the different types of information resources available in Pharmacovigilance with Drug Dictionaries and coding used in Pharmacovigilance. (RGPV Jun 2020)
Unit- III Vaccine Safety Surveillance
Q.1 Discuss the procedure, merits and demerits of observational studies. (RGPV May 2024)
Q.2 Explain about the passive surveillance methods. (RGPV May 2024)
Q.3 Emphasize on passive and active surveillance and discuss case control and cohort study. (RGPV May 2022)
Q.4 What is Vaccine safety surveillance? Explain in detail different types of pharmacovigilance methods used for passive and active surveillance. (RGPV Jun 2020)
Q.5 Explain in detail methods used for effective communication in Pharmacovigilance with special reference with regulatory agencies. (RGPV Jun 2020)
Unit-IV Safety Data Generation
Q.1 Describe briefly the clinical phase and Periodic safety update reports as per ICH guidelines. ICH (RGPV May 2024)
Q.2 Discuss post approval expedited reporting as per ICH guidelines for Pharmacovigilance. (RGPV May 2022)
Q.3 Discuss in detail about Safety data generation. (RGPV May 2022)
Q.4 What is the organization and objective of ICH guidelines in Pharmacovigilance? Explain in detail good clinical practices in Pharmacovigilance studies. (RGPV Jun 2020)
Unit-V Pharmacogenomics of Adverse Drug Reactions
Q.1 Explain how to establish a drug safety department in the industry. (RGPV May 2024)
Q.2 Illustrate the criteria for drug safety evaluation in Geriatrics. (RGPV May 2024)
Q.3 Write the differences between Indian and global pharmacovigilance requirements. (RGPV May 2024)
Q.4 Write short notes on (Any two): (RGPV May 2022)
a) MedDRA
b) CDSCO and Pharmacovigilance
c) CIOMS
Q.5 Explain in detail different Pharmacovigilance evaluation methods used for drug safety in special populations. (RGPV Jun 2020)
Q.6 Write short notes on (any two). (RGPV Jun 2020)
a) CIOMS
b) CDSCO and Pharmacovigilance
c) MedDRA
Extra Questions
Q.1 Write a short note on (any two): (RGPV May 2024)
a) Severity and Seriousness assessment
b) Working groups of CIOMS
c) Individual case safety reports
Q.2 Write notes on: (RGPV May 2022)
a) Schedule Y
b) Daily defined doses
— Best of Luck for Exam —
