Date: 27 November 2019
Question 1. What Is Pharmacovigilance?
Answer :
Pharmacovigilance is the science of collecting, monitoring, researching, assessing and evaluating information from healthcare providers and patients on the adverse effects of medications, biological products, herbalism and traditional medicines
Question 2. What Is The Minimum Criterion Required For A Valid Case?
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Question 3. What Is An Adverse Drug Event (ade)?
Answer :
Any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment.
Question 4. What Is An Adverse Drug Reaction (adr)?
Answer :
An adverse drug reaction is a “response to a drug which is noxious and unintended and which occurs at doses normally used in man for prophylaxis, diagnosis, or therapy of disease or for the modification of physiologic function.” Note that there is a causal link between a drug and an adverse drug reaction. In sum, an adverse drug reaction is harm directly caused by the drug at normal doses, during normal use.
Question 5. What Is The Difference Between An Ade And Adr?
Answer :
There may not be a causal relationship between a drug and an ADE, whereas, there is a causal link between a drug and an adverse drug reaction.
Question 6. What Is Volume 9a?
Answer :
Volume 9A brings together general guidance on the requirements, procedures, roles and activities in the field of pharmacovigilance, for both Marketing Authorisation Holders (MAH) and Competent Authorities of medicinal products for human use; it incorporates international agreements reached within the framework of the International Conference on Harmonisation (ICH).
Volume 9A is presented in four parts:
Question 7. When Do You Consider A Case To Be Medically Confirmed?
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Question 8. What Do You Mean By Causality?
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Question 9. Name Some Data Elements In Icsr?
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Question 10. What Should A Narrative Consist Of?
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A narrative should consist of precise and concise information about the source of report, patient demographics, patient’s medical history, concomitant medications, suspect product details and adverse event details in an orderly manner.
Question 11. What Do You Mean By Meddra?
Answer :
Medical Dictionary for Regulatory Activities.
Question 12. Explain The Hierarchy In Meddra?
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Question 13. What Do You Know About E2a, E2b And E2c Guidelines?
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E2a: E2a guidelines give standard definitions and terminology for key aspects of clinical safety reporting. It also gives guidance on mechanisms for handling expedited (rapid) reporting of adverse drug reactions in the investigational phase of drug development.
E2b: E2b guidelines for the maintenance of clinical safety data management and information about the data elements for transmission of Individual Case Safety Reports.
E2c: E2b guidelines for the maintenance of clinical safety data management and information about the Periodic Safety Update Reports for marketed drugs.
Question 14. What Are Data Assessments In Pharmacovigilance?
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Data assessments are:
Question 15. What Are The Types Of Pharmacovigilance (pv)?
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Question 16. When Do You Consider An Event To Be Serious?
Answer :
If an event is associated with any one of the following, it is considered to be serious
Question 17. Name The Regulatory Bodies In Usa, Uk, Japan And India?
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