B Pharm 8th Sem Pharmacovigilance Imp Questions 2024

In this post pharmacovigilance important questions 8 sem b pharmacy are given for 2024. 

Considering all these questions as essential, prepare answers to them. 

If you prepare accurate answers to all these questions then you can get good marks in the examination. 

It is not that only these questions will be asked in the examination. 

Apart from these, you will also be asked more questions related to the pharmacovigilance topic. 

These questions can also be asked in the exam by twisting them. 

The pattern of the pharmacovigilance 8th sem question paper given here has been prepared according to the format of the previous question paper. 

So that you can get accurate information about the pattern of the exam question paper. 

You should try to write the answers to all the pharmacovigilance basic questions given here in your own words and prepare excellent notes. 

To do this, your concept on this topic should be clear. Before writing the answers, read the lessons related to this topic carefully from your textbook 2 to 3 times and try to understand their meaning. 

If you have any difficulty understanding any question or writing the answer, take the help of your professor or Advanced Pharma book. 

All the questions given here have been taken from pharmacovigilance previous year question paper and question bank, an attempt has been made to include those questions which have been asked repeatedly and are likely to be asked in the upcoming examination. 

Therefore do not skip any question. 

When you are given a pharmacovigilance b pharm 8th sem question paper in the examination hall, then the first thing you should do is check the entire question paper. 

Make sure that there is no page missing or any question misprinted in the question paper. 

If this happens, inform the invigilator and request a fresh question paper. 

Start writing your answers only after reading the instructions given on the first page of the pharmacovigilance question paper received in the examination and express your views in as many words as have been asked to write the answer. 

Your written answers should be informative and according to the question. 

Let us solve all the important questions of pharmacovigilance question bank 8th sem given here.

Pharmacovigilance Questions

Pharmacovigilance B Pharm 8th Sem Important Questions

• Describe in details CDSCO in India.
• Discuss the Pharmacovigilance Programme in the Hospitals.
• Discuss in detail of Cohort and case-control study.
• Discuss the Risk Factors for Vaccine Failure. Write a note on the risk-benefit assessment of the vaccine.
• Write the advantages and disadvantages of case-control studies in vaccine safety evaluation.
• Why CIOMS is important within Pharmacovigilance Work.
• Write a note on Expedited reporting.
• Define Adverse Drug Reactions. 
• Write the applications of Pharmacovigilance.
• Explain the Post-Marketing Trials.
• Explain the responsibilities of the Ethics Committee as per Schedule Y.
• What are periodic Safety Update Reports?
• What is the importance of safety monitoring?
• Write a short notes on Pharmacovigilance Planning.
• What is the basic purpose of the National Pharmacovigilance Programme?
• Discuss the causality, severity, and seriousness assessment of Adverse Drug Reactions in detail.
• Explain the term Daily Defined Doses. Defined daily dose in Pharmacovigilance.
• Explain the Good Pharmacovigilance Practice.
• What are the basic drug information resources?
• Write short notes on the following:- (a) Safety Data Management (b) Common technical document (c) Elements of the Specification (d) Registries.
• Write the Detection and Reporting Program of ADR.
• What is teratogenicity? Explain with an example.
• Explain the standardized Med DRA queries.
• Explain the immunization safety surveillance system. Define safety surveillance.
• Write a short answer on the classification of ADRs on an etiological basis.
• Write drug safety evaluations in geriatric and pediatric populations.
• Write short notes on the following:- (a) Harmonization (b) COSTART and INNM (c) Contract Research Organization (d) Functions of CIOMS.
• Write a note on a Cross-sectional study.
• What is Drug event monitoring?
• Discuss in detail basic and specialized drug information resources in Pharmacovigilance.
• Write short answers on the following:- (a) Pharmacogenomics (b) Partners in Pharmacovigilance (c) Examples of Active surveillance system.
• Discuss the importance of effective communication in Pharmacovigilance.
• Explain the various pharmacovigilance methods.
• Explain predisposing factors of adverse drug reactions.
• What is the role of the Eudravigilance of PV in Europe?
• Explain individual case study reports.
• Write short notes on the following:- (a) Sentinel sites as active surveillance (b) Mention a few primary sources of drug information (c) Preventability Assessment Method (d) History of ICH & ICH Steering Committee (e) Standardized MedDRA queries.
• Describe the Safety monitoring of medicine.
• What are the ADR detection and reporting programs?
• What is idiosyncrasy?
• Discuss in detail drug safety evaluation in pregnant and lactating women.
• Write the responsibility of the Indian Pharmacopoeia Commission.
• Write a note on the Post Approval Phase. Write the importance of post-approval expedited reporting.
• What factors should be considered for the drug safety evaluation in Geriatrics?
• Define the drug safety crisis management.
• Write a note on Pharmacovigilance of India. Explain the History and Scope of Pharmacovigilance.
• Explain the Working Group XII and XI objectives.
• Write about the organization and functions of the International Council on Harmonization.
• Write a note on the Anatomical Therapeutic Chemical classification of drugs.
• Write short notes on the following:- (a) Prescription event monitoring (b) Genetic polymorphism (c) Stimulated reporting.
• Write the international classification of diseases.
• What is the importance of vaccine safety?
• What types of services are provided by CROs.
• What is the preclinical phase?
• Write a note on clinical trial regulations in India.
• Write short notes on the following:- (a) Methods of communication (b) WHO drug dictionary (c) Dechallenge (d) Derived Classification.

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