Question 1. What Is Pharmacovigilance?
Pharmacovigilance is the technological know-how of amassing, tracking, discovering, assessing and evaluating records from healthcare providers and sufferers at the destructive effects of medications, organic products, herbalism and conventional drug treatments
Question 2. What Is The Minimum Criterion Required For A Valid Case?
An identifiable reporter
An identifiable patient
A suspect product
An destructive drug event
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Question three. What Is An Adverse Drug Event (ade)?
Any untoward clinical prevalence in a affected person or medical research challenge administered a pharmaceutical product and which does no longer necessarily have to have a causal dating with this treatment.
Question four. What Is An Adverse Drug Reaction (adr)?
An destructive drug reaction is a “response to a drug that's noxious and unintentional and which occurs at doses generally utilized in man for prophylaxis, analysis, or remedy of disorder or for the modification of physiologic characteristic.” Note that there may be a causal link among a drug and an negative drug response. In sum, an adverse drug reaction is harm directly caused by the drug at normal doses, at some stage in ordinary use.
Question 5. What Is The Difference Between An Ade And Adr?
There won't be a causal dating between a drug and an ADE, while, there may be a causal link among a drug and an unfavourable drug response.
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Question 6. What Is Volume 9a?
Volume 9A brings together trendy steering at the requirements, processes, roles and activities in the discipline of pharmacovigilance, for both Marketing Authorisation Holders (MAH) and Competent Authorities of medicinal products for human use; it includes worldwide agreements reached inside the framework of the International Conference on Harmonisation (ICH).
Volume 9A is presented in four parts:
Part I deals with Guidelines for Marketing Authorisation Holders;
Part II offers with Guidelines for Competent Authorities and the Agency;
Part III presents the Guidelines for the electronic trade of pharmacovigilance in the EU
Part IV presents Guidelines on pharmacovigilance communication
Question 7. When Do You Consider A Case To Be Medically Confirmed?
A case is taken into consideration to be medically confirmed if it carries at least one occasion showed or suggested by way of an HCP (Health Care Professional)
Note: HCP can be a physician, nurse, pharmacist, coroner or psychologist (best in Germany).
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Question eight. What Do You Mean By Causality?
Causality is the relationship between a hard and fast of factors. In Pharmacovigilance, causality is the connection among the suspect product and the unfavorable drug event.
Question nine. Name Some Data Elements In Icsr?
Patient demographics: Age, gender and race.
Suspect product info: Drug, dose, dosage form, remedy dates, therapy duration and indication. Adverse occasion info: Event, event onset date, seriousness criterion, occasion end date and latency.
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Question 10. What Should A Narrative Consist Of?
A narrative must encompass particular and concise information approximately the supply of record, patient demographics, patient’s scientific history, concomitant medicines, suspect product information and negative occasion details in an orderly way.
Question 11. What Do You Mean By Meddra?
Medical Dictionary for Regulatory Activities.
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Question 12. Explain The Hierarchy In Meddra?
System Organ Class (SOC)
High Level Group Term (HLGT)
High Level Term (HLT)
Preferred Term (PT)
Lower Level Term (LLT)
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Question thirteen. What Do You Know About E2a, E2b And E2c Guidelines?
E2a: E2a guidelines supply preferred definitions and terminology for key aspects of clinical protection reporting. It also gives steering on mechanisms for managing expedited (speedy) reporting of unfavorable drug reactions inside the investigational section of drug improvement.
E2b: E2b pointers for the protection of medical safety records control and information approximately the records factors for transmission of Individual Case Safety Reports.
E2c: E2b hints for the maintenance of scientific protection information control and records approximately the Periodic Safety Update Reports for marketed pills.
Question 14. What Are Data Assessments In Pharmacovigilance?
Data assessments are:
Individual case record evaluation
Aggregated assessment and interpretation
Interactions and danger factors
Question 15. What Are The Types Of Pharmacovigilance (pv)?
Two kinds. 1. Active PV and a couple of.Passive PV
Active PV: Active (or proactive) safety surveillance means that energetic measures are taken to locate negative activities. This is controlled by active follow-up after remedy and the events can be detected with the aid of asking sufferers immediately or screening patient statistics. The maximum comprehensive method is cohort occasion monitoring (CEM)
Passive PV: Passive surveillance manner that no energetic measures are taken to look for unfavorable consequences aside from the encouragement of fitness professionals and others to report safety concerns. Reporting is depending on the initiative and motivation of the capacity journalists. This is the most common shape of pharmacovigilance. It is normally known as “spontaneous” or “voluntary” reporting.
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Question 16. When Do You Consider An Event To Be Serious?
If an occasion is associated with any person of the subsequent, it's miles taken into consideration to be serious
Hospitalization or prolongation of hospitalization.
Question 17. Name The Regulatory Bodies In Usa, Uk, Japan And India?
USA: United States Food and drug management (USFDA).
UK: European Medicines Agency (EMEA).
Japan: Ministry of Health, Labour and Welfare (MHLW).
India: Central Drugs Standard Control Organization (CDSCO)
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