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What is pharmacovigilance? Answer: Pharmacovigilance is the science and activities related to the detection, assessment, understanding, and prevention of adverse effects or any other drug-related problems.
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What is the difference between a serious and non-serious adverse drug reaction (ADR)? Answer: A serious adverse drug reaction is an ADR that results in death, is life-threatening, requires hospitalization or prolongation of existing hospitalization, results in persistent or significant disability or incapacity, or is a congenital anomaly or birth defect. A non-serious ADR is any ADR that is not serious.
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What is signal detection in pharmacovigilance? Answer: Signal detection is the process of identifying new or unrecognized safety concerns related to a drug by analyzing data from various sources, such as spontaneous reports, clinical trials, epidemiological studies, and literature.
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What is the difference between pharmacovigilance and clinical trials? Answer: Clinical trials are conducted before a drug is marketed to determine its safety and efficacy. Pharmacovigilance, on the other hand, is the ongoing monitoring of the safety of a drug after it has been approved and marketed.
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What is the role of the Pharmacovigilance Risk Assessment Committee (PRAC)? Answer: The PRAC is responsible for assessing and managing the risk of adverse effects of human medicines and providing recommendations to the European Medicines Agency (EMA).
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What is the role of the International Conference on Harmonization (ICH) in pharmacovigilance? Answer: The ICH develops guidelines for the pharmaceutical industry to ensure the quality, safety, and efficacy of drugs. Its guidelines for pharmacovigilance provide a framework for the collection, analysis, and reporting of safety data.
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What is a Periodic Safety Update Report (PSUR)? Answer: A PSUR is a report submitted by the marketing authorization holder of a drug to regulatory authorities that summarizes the safety information of the drug at defined intervals after its approval.
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What is a Risk Management Plan (RMP)? Answer: An RMP is a plan that outlines the safety concerns of a drug and the measures that will be taken to minimize those risks.
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What is the difference between a risk and a hazard in pharmacovigilance? Answer: A hazard is a potential source of harm, whereas a risk is the probability that harm will occur.
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What is the role of the Data Monitoring Committee (DMC) in clinical trials? Answer: The DMC is responsible for reviewing the safety data of a clinical trial and making recommendations to the trial sponsor and the regulatory authority regarding the continuation or modification of the trial.
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What is the difference between an adverse event and an adverse drug reaction? Answer: An adverse event is any untoward medical occurrence that may occur during treatment with a drug, regardless of whether it is related to the drug. An adverse drug reaction is a response to a drug that is noxious and unintended and occurs at doses normally used in humans for prophylaxis, diagnosis, or therapy.
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What is the role of a safety signal in pharmacovigilance? Answer: A safety signal is information that suggests a new or incompletely documented adverse event that may be caused by a drug.
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What is the difference between a spontaneous report and an active surveillance report in pharmacovigilance? Answer: A spontaneous report is a report of an ADR that is submitted voluntarily by healthcare professionals or patients. Active surveillance involves actively collecting data on ADRs through methods such as electronic health records, registry-based surveillance,and prescription event monitoring.
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What is the purpose of post-authorization safety studies (PASS) in pharmacovigilance? Answer: The purpose of PASS is to further evaluate the safety of a drug after its approval and marketing, typically in a specific population or for a specific indication.
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What is the role of the World Health Organization (WHO) in pharmacovigilance? Answer: The WHO provides global leadership in pharmacovigilance and coordinates international efforts to monitor the safety of medicines.
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What is a pharmacovigilance system master file (PSMF)? Answer: A PSMF is a comprehensive document that describes the pharmacovigilance system of a marketing authorization holder, including its organization, procedures, and responsibilities.
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What is the difference between a benefit-risk assessment and a risk-benefit assessment in pharmacovigilance? Answer: A benefit-risk assessment evaluates the overall benefit of a drug compared to its risks, while a risk-benefit assessment evaluates the overall risk of a drug compared to its benefits.
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What is the role of the European Medicines Agency (EMA) in pharmacovigilance? Answer: The EMA is responsible for the scientific evaluation of medicines in the European Union and monitors the safety of medicines after they have been approved.
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What is the difference between a quantitative and a qualitative signal in pharmacovigilance? Answer: A quantitative signal is a signal that is based on numerical data, such as the frequency of a particular adverse event. A qualitative signal is a signal that is based on non-numerical data, such as the nature or severity of an adverse event.
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What is the purpose of the EudraVigilance database in pharmacovigilance? Answer: The EudraVigilance database is a centralized database for the collection and analysis of suspected ADRs for medicines authorized in the European Economic Area.
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What is the role of the FDA in pharmacovigilance? Answer: The FDA is responsible for regulating the safety and efficacy of drugs in the United States and monitors the safety of drugs after they have been approved.
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What is the difference between a population-based and a hospital-based study in pharmacovigilance? Answer: A population-based study involves analyzing data from a general population, while a hospital-based study involves analyzing data from a specific hospital or group of hospitals.
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What is the role of the Qualified Person for Pharmacovigilance (QPPV)? Answer: The QPPV is responsible for overseeing the pharmacovigilance activities of a marketing authorization holder and ensuring compliance with regulatory requirements.
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What is the purpose of the Medical Dictionary for Regulatory Activities (MedDRA) in pharmacovigilance? Answer: MedDRA is a standardized medical terminology that is used for the classification and coding of ADRs and other medical events.
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What is the role of the Drug Safety Monitoring Board (DSMB) in clinical trials? Answer: The DSMB is an independent committee that monitors the safety and efficacy of a clinical trial and makes recommendations to the trial sponsor regarding the continuation or modification of the trial.
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What is the difference between a cohort study and a case-control study in pharmacovigilance? Answer: A cohort study follows a group of individuals over time to determine the incidence of a particular adverse event, while a case-control study compares the frequency of a particular adverse event in cases (individuals with the event) and controls (individuals without the event).
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What is the role of the Adverse Drug Reaction Electronic System (ADRES) in pharmacovigilance? Answer: ADRES is a web-based platform used by the Philippines Food and Drug Administration (FDA) to report and monitor suspected ADRs of drugs marketed in the Philippines.
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What is the difference between a safety signal and a safety alert in pharmacovigilance? Answer: A safety signal is an indication that there may be an increased risk of an adverse event associated with a drug, while a safety alert is a notification to healthcare professionals of a specific safety concern.
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What is the role of the Periodic Safety Update Report (PSUR) in pharmacovigilance? Answer: The PSUR is a comprehensive report that provides an updated safety profile of a drug, based on data from clinical trials, post-marketing studies, and other sources.
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What is the role of the International Conference on Harmonization (ICH) in pharmacovigilance? Answer: The ICH is a global organization that develops guidelines for the development, registration, and post-marketing surveillance of drugs, including pharmacovigilance activities.
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What is the difference between pharmacovigilance and pharmacoepidemiology? Answer: Pharmacovigilance focuses on monitoring and managing the safety of drugs after they have been marketed, while pharmacoepidemiology focuses on studying the effects of drugs in populations.
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What is the role of the electronic health record (EHR) in pharmacovigilance? Answer: The EHR can be used to identify potential ADRs and monitor their occurrence in a clinical setting.
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What is the role of data mining in pharmacovigilance? Answer: Data mining can be used to identify potential safety signals from large volumes of data, such as electronic health records and social media.
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What is the difference between an adverse event and an adverse drug reaction? Answer: An adverse event is any undesirable experience associated with the use of a drug, while an adverse drug reaction is a response to a drug that is noxious and unintended and occurs at doses normally used in humans for prophylaxis, diagnosis, or therapy.
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What is the role of the Good Pharmacovigilance Practices (GVP) guidelines in pharmacovigilance? Answer: The GVP guidelines provide a set of standards for the conduct of pharmacovigilance activities throughout the European Union.
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What is the role of the Signal Detection and Management team in pharmacovigilance? Answer: The Signal Detection and Management team is responsible for identifying and evaluating potential safety signals and making recommendations for further investigation.
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What is the difference between a serious and non-serious adverse event? Answer: A serious adverse event is any event that results in death, is life-threatening, requires hospitalization or prolongation of existing hospitalization, results in persistent or significant disability or incapacity, or is a congenital anomaly/birth defect. A non-serious adverse event is any adverse event that does not meet these criteria.
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What is the role of the Risk Management Plan (RMP) in pharmacovigilance? Answer: The RMP is a comprehensive plan that outlines the measures that a marketing authorization holder will take to minimize the risks associated with a drug and maximize its benefits.
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What is the difference between a black box warning and a contraindication? Answer: A black box warning is the strongest warning that the FDA requires and alerts healthcare professionals and patients to potentially serious or life-threatening risks associated with a drug. A contraindication is a situation where the use of a drug is not recommended due to potential harm to the patient.
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What is the role of the Patient Safety Organization (PSO) in pharmacovigilance? Answer: The PSO is a private or public organization that is certified by the Agency for Healthcare Research and Quality (AHRQ) to collect, analyze, and report patient safety information, including ADRs.
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What is the role of the EudraVigilance database in pharmacovigilance? Answer: The EudraVigilance database is a European Union (EU)-wide database that collects, manages, and analyzes information on suspected adverse reactions to medicinal products authorized in the EU.
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What is the role of the Drug Safety Update (DSU) in pharmacovigilance? Answer: The DSU is a monthly bulletin published by the UK Medicines and Healthcare Products Regulatory Agency (MHRA) that provides updates on drug safety issues, including new ADRs, changes to prescribing information, and safety alerts.
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What is the difference between risk assessment and risk management in pharmacovigilance? Answer: Risk assessment is the process of evaluating the potential risks associated with a drug, while risk management is the process of implementing strategies to minimize those risks.
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What is the role of the Vaccine Adverse Event Reporting System (VAERS) in pharmacovigilance? Answer: VAERS is a national vaccine safety surveillance program in the United States that collects and analyzes information on adverse events that occur after vaccination.
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What is the role of the Spontaneous Reporting System (SRS) in pharmacovigilance? Answer: The SRS is a system for collecting and analyzing reports of suspected ADRs that are voluntarily submitted by healthcare professionals and patients.
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What is the difference between a Type A and Type B adverse drug reaction? Answer: A Type A ADR is a predictable and dose-related ADR that is commonly observed with a drug, while a Type B ADR is an unpredictable, idiosyncratic, and not dose-related ADR that is rare and often serious.
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What is the role of the Pharmacovigilance Risk Assessment Committee (PRAC) in pharmacovigilance? Answer: The PRAC is a scientific committee of the European Medicines Agency (EMA) that is responsible for assessing and managing the risks associated with medicinal products.
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What is the role of the MedDRA terminology in pharmacovigilance? Answer: MedDRA is a standardized medical terminology used for the classification and coding of ADRs and other medical events.
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What is the difference between a drug interaction and a drug-drug interaction in pharmacovigilance? Answer: A drug interaction is a modification of the effect of a drug by another drug or a food, while a drug-drug interaction is a specific type of drug interaction that occurs between two or more drugs.
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What is the role of the Center for Drug Evaluation and Research (CDER) in pharmacovigilance? Answer: The CDER is a division of the FDA that is responsible for the regulation of drugs, including the assessment of their safety and efficacy, and the monitoring of their safety after they are approved.