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No, it does not necessarily have to have a causal relationship with the treatment.

By providing timely information about safety to patients, healthcare professionals, and the public.

The relationship between the suspect product and the adverse drug event.

Any unfavorable or unintended sign, symptom, or disease associated with the use of a medicinal product.

Development Safety Update Report.

Yes, it can include any unfavorable and unintended sign, symptom, or disease temporally associated with the use of a medicinal product.

Direct Healthcare Professional Communication.

From use within or outside the marketing authorisation or from occupational exposure.

Data Lock Point.

The first date on which any representative of an organization was notified of the minimum essential elements for expedited reporting.

United States Food and Drug Administration (USFDA).

Suspected Unexpected Serious Adverse Reaction.

Making a medicinal product available for compassionate reasons to patients with seriously debilitating or life-threatening diseases who cannot be treated satisfactorily with authorized products.

An international classification of drugs providing proprietary and non-proprietary names of medicinal products used in different countries, together with all active ingredients.

An organised system that collects uniform data on specified outcomes in a defined population based on disease, condition, or exposure.

Important medical event.

The absence of expected or desired effect related to a therapy.

It must be subject to an application for central marketing authorization or undergoing clinical trials.

Periodic Reporting.

EV.

Chronically or seriously debilitating diseases and life-threatening diseases.

Quarterly.

An identifiable reporter, an identifiable patient, a suspect product, and an adverse drug event.

Any untoward medical occurrence in a patient following the administration of a pharmaceutical product, which may not necessarily have a causal relationship with the treatment.

An investigation in human subjects to discover or verify clinical and pharmacological effects, identify adverse reactions, and study pharmacokinetics of investigational medicinal products.

If it contains at least one event confirmed or reported by a Health Care Professional (HCP).

Programs designed to assist patients in managing their treatment and therapy.

It must be submitted within fifteen (15) calendar days.

Precise and concise information about the source of the report, patient demographics, medical history, concomitant medications, suspect product details, and adverse event details in an orderly manner.

Ministry of Health, Labour and Welfare (MHLW).

When the adverse event subsides or disappears after the removal of the drug.

It involves the process of identifying illnesses, preventing their occurrence, monitoring progress, and providing treatment or alleviation.

EU Reference Date.

International non-proprietary name.

Central Drugs Standard Control Organization (CDSCO).

Events that do not meet specific criteria but are serious enough that treatment is needed to prevent more severe outcomes.

Marketing authorisation.

15 days.

When a doctor unintentionally prescribes/administers a drug by an unauthorized route of administration.

Advanced therapy medicinal product.

Qualified Person responsible for Pharmacovigilance.

A validated signal that has been determined to be 'false' after further assessment.

Administration of a quantity of a medicinal product above the maximum recommended dose according to the authorized product information.

Results in death, is life-threatening, or requires inpatient hospitalization.

Good pharmacovigilance practice (GVP) guidelines.

An adverse event that has a causal association with a drug.

Uppsala Monitoring Centre.

Off-label use, overdose, misuse, abuse, and medication errors.

Very common (>10%), Common (>1% and <10%), Uncommon (>0.1% and <1%), Rare (>0.01% and <0.1%), Very rare (<0.01%).

Guidelines released by the European Medicines Agency for good pharmacovigilance practices.

Persistent or significant disability/incapacity, congenital anomaly (birth defect), or medically significant events requiring treatment.

Electronic Common Technical Document.

Adverse event following immunization.

Requirements, procedures, roles, and activities in pharmacovigilance.

Adverse event of special interest.

European Economic Area.

Core data sheets.

Additional risk minimization measure.

To compile safety data for a drug over a prolonged period.

Benefit-risk assessments.

Module XV – Safety communications, Module XVI – Risk minimisation measures, Module XVI Addendum I – Educational materials, Module XVI Addendum II – Methods for effectiveness evaluation.

Aggregate Reporting compiles data over time, while single-case reporting involves individual AE reports.

A comprehensive annual review and evaluation of safety information collected during the reporting period related to a drug under investigation.

The date designated based on the international birth date.

Company core data sheet.

The date of approval of the first authorization for conducting an interventional clinical trial in any country.

Marketing-authorisation holders, EMA, and regulatory authorities in EU Member States.

Company core safety information.

Programs that allow individual patients access to unapproved therapies.

It must be reported within seven (7) calendar days.

Physicians, nurses, pharmacists, etc.

Yes, clinical trials can be carried out in one or multiple sites and in one or more Member States.

Pharmaceutical companies, clinical trial organizations, and drug regulatory authorities.

An adverse reaction inconsistent with the applicable product information.

The largest repository of drug safety data across the globe, maintained by Uppsala Monitoring Centre (UMC).

Yes, it can also refer to beneficial but unintended consequences of drug use.

Patients with chronically or seriously debilitating diseases or those whose conditions are life-threatening.

Council for International Organizations of Medical Sciences.

That the event persists even after removal of the drug, indicating a causal relationship is unlikely.

7 days.

Title page, Executive Summary, Table of Contents, Introduction, Worldwide Marketing Approval Status.

It must include details of suspected adverse reactions related to a medicinal product for a specific patient.

Preferred term.

EudraVigilance Clinical Trial Module.

Marketing authorisation holder.

It can be closed because it is refuted or determined to be a potential or identified risk.

European Public Assessment Report.

Further analysis of the detected signal.

Prescribing, storage, dispensing, preparation, and administration.

Randomised clinical trial.

As signals that have been refuted as 'false' based on medical judgment and scientific evaluation.

The date designated based on the development international birth date.

Harm from adverse reactions in humans arising from authorized medicinal products.

A noxious and unintended response to a medicinal product with a reasonable possibility of a causal relationship.

To ascertain the safety and/or efficacy of one or more investigational medicinal products.

It contributes to the protection of patient and public health.

AE may not have a causal relationship with a drug, while ADR always does.

Designated Medical Event.

An effect, whether therapeutic or adverse, that is secondary to the one intended.

An analysis of the risk-benefit profile of a medicinal product based on safety, efficacy, and effectiveness information.

An untoward and unintended response to a study drug that meets serious criteria.

The international reporting form.

Disease state, age, weight, gender, ethnicity, and general health.

Therapeutic Goods Administration (TGA).

The organisational structure, responsibilities, procedures, processes, resources, and resource management within the pharmacovigilance framework.

Using a medicinal product for a medical purpose not in accordance with the terms of the marketing authorization.

Marketing Authorisation Holders (MAH) and Competent Authorities.

When the adverse event reappears after the drug is reintroduced, strongly suggesting a causal relationship.

A study where medicinal products are prescribed in the usual manner according to marketing authorization.

They may contain lower quality substances, wrong doses, or be mislabelled to hide the source.

Strength of the evidence, clinical relevance, and previous awareness of the association.

A Periodic Adverse Drug Experience Report submitted to the USFDA as part of post-cumulative safety reports.

90 days.

EudraVigilance Data Analysis System.

The administration of a drug again to a patient after its previous withdrawal.

Patterns of medication errors and potential medication errors.

The science and activities related to the detection, assessment, understanding, and prevention of adverse effects or any medicine-related problem.

An occurrence that may not be causally related to a drug.

Development International Birth Date.

The entire life-cycle of a medicinal product.

Medicines and Healthcare Regulatory Agency (MHRA).

A medicinal product for human use related to gene therapy, somatic cell therapy, or tissue engineering.

A PSUR serves as an interval safety report, whereas a PBRER is a cumulative benefit-risk report.

Results in death, is life-threatening, requires hospitalization, results in persistent disability, or is a congenital anomaly.

Electronic Reaction Monitoring Report.

Periodic safety update reports manual.

Different groups of patients receiving medication.

Uppsala Monitoring Centre (UMC).

Evaluating data to verify the existence of a new potentially causal association or a new aspect of a known association.

Intentionally and inappropriately using a medicinal product not in accordance with the authorized product information.

An unexpectedly increased rate of fatal or life-threatening adverse events.

To withdraw a drug and monitor its effect on an adverse event.

Persistent or sporadic, intentional excessive use of medicinal products causing harmful physical or psychological effects.

Counterfeit packaging, wrong ingredients, or a lower proportion of the active substance.

An adverse reaction with strong causality supported by temporal relationship and biological plausibility, such as anaphylactic reactions.

To be used for diagnostic and/or therapeutic purposes in human beings.

They play a key role in the risk-benefit evaluation of the drug.

Atypical or accelerated progression of disease indicating poor efficacy of the product.

Exposure to a medicinal product as a result of one’s professional or non-professional occupation for reporting suspected adverse reactions.

Medical Dictionary for Regulatory Activities.

Collective case analysis, monitoring regulatory actions, and literature searches.

Periodic Safety Update Report.

It refers to the withdrawal of a drug suspected of causing an adverse event.

The Council for International Organizations of Medical Sciences, established jointly by WHO and UNESCO in 1949 as a non-profit organization.

Regulation (EC) No 1394/2007.

The study of different doses of medication.

Data on efficacy and effectiveness from ongoing or updated clinical trials and cohort studies.

It is a report detailing one or several suspected adverse reactions to a medicinal product occurring in a single patient at a specific point in time.

Lack of efficacy/effect.

When a doctor intentionally prescribes/administers a drug by an unauthorized route of administration.

An unintended failure in the drug treatment process that may harm the patient.

European Medicines Agency.

The date designated for data to be included in a PSUR.

Human or process-mediated failures, not lack of drug efficacy.

Developmental International Birth Date.

A set of measures to facilitate pharmacovigilance in the EU.

A validated signal in EPITT that does not require further analysis and prioritization by PRAC at that time.

Administering medicine by methods not approved for its use.

To assure regulators that sponsors are adequately monitoring and evaluating the evolving safety profile of the investigational drug.

Adverse reactions included in section 4.8 of the SmPC, unless they are class-related reactions not specifically described with this product.

When the adverse event subsides or disappears after the drug is removed.

A signal first identified during the reporting interval, prompting further actions or evaluation.

Healthcare professionals, patients, or consumers.

Yes, they cover centrally and nationally authorized medicines.

To help ensure that the benefits of a medication outweigh its risks.

Various regulatory agencies.

The approval of a medicinal product for sale in different regions.

Placebo, an active substance, or non-exposure.

Pharmacovigilance system master file.

No, they do not.

To provide an evaluation of the risk-benefit balance of a medicinal product for submission during the post-authorisation phase.

A signal for which an evaluation was completed during the reporting interval.

International agreements from the International Conference on Harmonisation (ICH).

Any instrument, apparatus, appliance, software, or material intended for diagnostic and/or therapeutic purposes for human beings.

It is not decided in advance by a trial protocol but falls within current practice.

Patients, consumers, healthcare professionals, medical information enquiries, literature reports, internet/digital media, clinical trials, non-interventional studies, and registries.

Practical issues in Pharmacovigilance.

Medication error.

A signal that remains under evaluation at the data lock point.

Reports derived from organized data systems, including clinical trials, non-interventional studies, and registries.

Clinical trial safety data.

Annually.

No, no additional procedures shall be applied.

The impact of findings on the benefit-risk balance of medicinal products.

EudraVigilance Medicinal Product Dictionary.

An untoward occurrence for which there is adequate evidence of an association with the medicinal product of interest.

The evaluation of the advantages and disadvantages of a medicinal product.

The seriousness of the risk and its impact on public health.

Practical aspects of signal detection in Pharmacovigilance.

National competent authority.

Actions can include product recalls, usage restrictions, or safety warnings.

It must contain sufficient evidence demonstrating the existence of a new association or aspect.

Medications with serious safety concerns.

To inform healthcare professionals of the need to take specific actions or adapt their practices related to a medicinal product.

Details of adverse drug experiences and relevant data as required.

Strong support from temporal relationship and biological plausibility.

To identify, characterize, prevent, or minimize risks related to medicinal products.

Serious Adverse Reaction.

Product information advising on specific clinical actions to minimize risk or additional risk minimisation activities.

The prescription is clearly separated from the decision to include the patient in the study.

European Pharmacovigilance Issues Tracking Tool.

To address potential patients’ or public health impacts that significantly affect the risk-benefit balance of a medicinal product.

It includes diagnosis, monitoring, treatment, and alleviation or compensation for a handicap.

A signal arises from a spontaneous adverse reaction reporting system, indicating an event associated with other active substances within the same class.

Faster progression than expected or unexpected elements attributed to treatment by the suspected product.

Data Lock Point.

Pharmacovigilance systems and their quality systems.

One or more suspected adverse reactions in patients given medicinal products.

European Clinical Trials Database.

The U.S. Food and Drug Administration (FDA).

Actions taken should be documented, or if unknown, the earliest known marketing authorization date for the product.

Reporting Odds Ratio.

To advance public health through guidance on health research and policy, including ethics, medical product development, and safety.

Through spontaneous reporting systems or scientific literature.

Drug type, seriousness, and causality.

Modifications regarding safety and efficacy related data since the last marketing authorization or renewal.

In the next periodic report.

On a periodic basis.

The expected number of patients using the product and how they use it.

Except for 15-day alert reports.

Reviewing cumulative safety information from a wide range of sources.

The treatment with a company product or the lack of effectiveness.

Interventions intended to prevent or reduce the occurrence of adverse reactions associated with a medicine.

Registries help gather and report information on adverse drug reactions.

In the PSUR (Periodic Safety Update Report) and PBRER (Periodic Benefit-Risk Evaluation Report).

Package leaflet.

Those risks that could impact the risk-benefit balance of the medicinal product when further characterized and confirmed.

To analyze patient exposure to a product over time after it has been marketed.

Reports received from healthcare professionals, patients, or consumers describing suspected adverse reactions not derived from a structured study.

EudraVigilance Expert Working Group.

Risk Evaluation and Mitigation Strategy.

Intentional use of a product in situations other than those described in the authorized product information.

The first anniversary of the DIBD.

A safety issue that requires urgent attention due to its potential major impact on risk-benefit balance.

A signal that lacks sufficient evidence for a new potentially causal association or a new aspect of a known association, warranting no further analysis.

A validated signal entered in the European Pharmacovigilance Issues Tracking Tool (EPITT) that requires further analysis by the PRAC.

Frequency, severity, seriousness, and outcome of the risk under normal conditions of use, and which populations are particularly at risk.

EudraVigilance Post-Authorisation Module.

Undesirable clinical outcomes for which there is sufficient scientific evidence that they are caused by the medicinal product.

A communication intervention by which important information is delivered to healthcare professionals regarding medicinal products.

The date of the first marketing authorization for any product containing the active substance granted in any country.

EudraVigilance Web Application.

Adverse events with a significant difference compared to the comparator group.

All existing safety experience with a medicinal product.

Reports can be derived from websites, forums, chat rooms, blogs, and social networks.

Any legal or illegal drugs.

In the Summary of Product Characteristics (SmPC).

An important identified risk that is likely to impact the risk-benefit balance of the product.

Good Clinical Practice.

The entire life-cycle of a medicinal product.

Drug Event Combination.

Good Pharmacovigilance Practices.

To evaluate all available data relevant to a signal to determine regulatory actions.

To assess the product's effectiveness and risks during the renewal period.

Signal evaluation.

It relates to signals concerning adverse effects.

System organ class.

A signal that has been verified to have sufficient evidence for a new potentially causal association or a new aspect of a known association, justifying further analysis.

The element of 'intention' at the prescriber level.

Risk minimisation measure.

European Union.

No, it does not include exposure to ingredients during the manufacturing process before the product is released.

Committee for Medicinal Products for Human Use.

International Birth Date.

Due to its potential impact on patient or public health.

Findings that have not been observed or resolved in clinical studies.

Investigation, replacement or modification of anatomy or physiological processes, and control of conception.

Any risk that is likely to be serious.

Reactions mentioned in the SmPC but not specifically described as occurring with the product.

Risk Management System.

Coordination Group for Mutual Recognition and Decentralised Procedures – Human.

Critical gaps in knowledge about a medicinal product related to safety or use in particular patient populations.

WHO and is an associate partner of UNESCO.

Major safety issues identified through reporting systems.

Post-authorisation safety study.

The effectiveness of the risk minimisation measures described in the Risk Management Plan (RMP).

It is essential for reevaluating the current benefit-risk balance to assure patients' health and safety.

Signal of disproportionate reporting.

In the DSUR, RMP, and PSUR/PBRER.

Through signal evaluation.

Collection, management and submission of reports of suspected adverse reactions.

A reaction between two or more drugs or between a drug and a food, beverage, or supplement.

It indicates the total exposure of subjects to a treatment over the duration of clinical trials.

They gather structured information on drug efficacy and safety.

To evaluate approved indications for a product.

Assessing safety data to determine potential risks associated with a product.

Evaluating the confirmed signals to make recommendations for action.

Reports from post-approval patient use programs or disease management programs.

Development safety update reports.

Medical Literature Monitoring.

Risk management plan.

To collect information on efficacy or patient compliance.

PRAC prioritizes signals for further analysis but may decide that some validated signals do not require immediate action.

Council for International Organizations of Medical Sciences.

An identified or potential risk that could impact the risk-benefit balance of the product or have implications for public health.

It helps determine whether a signal is refuted or should be considered valid.

Addendum to the Clinical Overview.

Pharmacological, immunological, or metabolic means.

Post-authorisation efficacy study.

At defined time points during the post-authorisation phase.

All cumulated effectiveness and safety data related to a medicinal product since marketing authorization (MA) or its last renewal.

Pharmacovigilance audits.

They provide solicited reports of suspect adverse reactions.

Continuing to consume the drug despite the impairment it causes.

Signal assessment by the Pharmacovigilance Risk Assessment Committee (PRAC).

Risk management systems.

To inform health care stakeholders about medication risks.

Relevant updates regarding medication errors and benefits during the evaluation period.

Higher Level Group Term and High-Level Term, respectively.

Ongoing safety monitoring and risk assessment.

The process of further evaluating a validated signal using all available evidence.

Duplicate management of suspected adverse reactions reports.

Taking a drug while having certain medical conditions can cause a drug interaction.

Summary of Safety Concerns.

The International Conference on Harmonization of Technical Requirements for Registration of Pharmaceuticals for Human Use.

Signal Evaluation.

Individual Case Safety Report.

Risks and New Information.

An untoward occurrence with some suspicion of association with the medicinal product, but where the association has not been confirmed.

MedWatch form (3500A) for each ADR not reported as a 15-day expedited report.

Epidemiological methods.

Periodic Benefit-Risk Evaluation Report.

The cut-off date for data and analyses presented in a document.

It provides a broader view of the safety profile of a drug.

Spontaneous reports are unsolicited, while solicited reports are gathered through structured systems.

A format and content for periodic reporting on drugs under development.

In the PSUR/PBRER as important or not important.

Serious Adverse Event.

Refer to listings of birth dates developed by some regions.

A set of activities to determine new risks or changes in known risks associated with a medicinal product based on various data sources.

The date of the first marketing authorisation in the EU of a medicinal product containing a specific active substance or combination.

Gaps in knowledge about safety for certain anticipated utilizations, such as long-term use.

Missing information.

Clinical trials or clinical practice.

There may be insufficient knowledge to determine whether the safety profile differs for particular patient populations.

The process of identifying signals using data from any source.

A causal relationship compared to the comparator group on a parameter of interest.

Safety profile, mechanisms of action, epidemiology, risk factors/groups, and available clinical/post-marketing experience.

The continuous process of identifying signals suggesting potential important risks.

Standardised MedDRA query.

International Birth Date.

Conditions imposed as part of the marketing authorization for a medicinal product.

A risk that could impact the risk-benefit balance of the product or have public health implications.

Non-clinical and clinical data.

A risk that, when characterized and confirmed, could impact the risk-benefit balance or public health.

Restriction of use or suspension of a medicinal product.

European Pharmacovigilance Issues Tracking Tool (EPITT).

Pharmacovigilance inspections.

The important identified risks likely to impact the risk-benefit balance of the product.

FDA Adverse Event Reporting System.

They may be scientifically suspected to have a causal relationship with the medicinal product.

Detailed description of the pharmacovigilance system.

Propose a birth date based on the earliest known marketing authorization and obtain regulatory authority’s agreement.

Signal detection, validation, confirmation, analysis and prioritization, assessment, and recommendation for action.

For medicinal products containing the same active substance or combination of active substances.

Summaries of safety and efficacy findings from clinical trials and noninterventional studies.

The current benefit-risk balance based on PSUR data and safety/efficacy data since the granting of the MA or the last renewal.

PhV.

EudraVigilance database.

Assessing the positive effects of a medicinal product.

Use in pregnant and lactating women or in the pediatric population without adequate clinical studies.

Individual case safety reports, aggregated data from surveillance systems, scientific literature, and other data sources.

Pregnancy prevention programme.

Taking a nasal decongestant if you have high blood pressure may cause an unwanted reaction.

Pharmacovigilance and Risk Assessment Committee.

A disease that negatively affects a person's brain and behavior.

Proportional reporting ratio.

In the DSUR, RMP, and PSUR/PBRER.

Trials that have finished and have no further subjects enrolled.

They are still in progress with active subject enrollment.

To reflect the increasing knowledge on risks and benefits and post-marketing experience.

Findings from Non-interventional Studies.

It refers to estimates of how many patients have used a product over a period.

Late-Breaking Information.

Preclinical or clinical considerations, even if potential risks have not been observed.

Periodic benefit-risk evaluation report.

They are a source for solicited reports regarding suspect adverse reactions.

Changes in frequency, distribution, duration, severity, or outcome.

Summary of product characteristics.

PSUR data and accumulated safety/efficacy data.

Measures and an assessment of the effectiveness of those interventions.

Identification and evaluation of new safety signals related to the medicinal product.

Whether there are new risks or changes in known risks associated with a medicinal product.

Periodic safety update report.

It encompasses key safety and efficacy data about the medicinal product.

Post-authorisation safety studies.

An important identified risk, important potential risk, or missing information.

A new renewal for the medicinal product.

Through pharmacovigilance activities and periodical safety reports like DSURs and PBRERs.

Methodological aspects of signal detection from spontaneous reports of suspected adverse reactions.

Additional monitoring.

Characterisation of Benefits.

Updates to safety data based on new findings or adverse event reports.

Other Periodic Reports.

Based on clinical considerations.

Continuously by the company.

Relevant safety and efficacy data affecting the benefit-risk assessment.

They provide a summary of serious adverse events recorded during clinical trials.

United States Food & Drug Administration.

Signal management.

Periodic safety update report.

Important Baseline Efficacy/Effectiveness Information.

A detailed description of the risk management system.

Information from Other Clinical Trials and Sources.

Compiled data showcasing findings from studies and reported adverse events.

Signal and Risk Evaluation.

Relevant additional information and data supporting the benefit-risk evaluation.

An evaluation of the positive therapeutic effects of a medicinal product in relation to its associated risks.

Discussing medical need and important alternatives.

Requirements and recommendations for submission of information on non-interventional post-authorisation safety studies.

Characterisation of Risks.

Safety issue, used interchangeably with the same definition.

A sufficient likelihood of a new potentially causal association.

Newly Identified information on Efficacy/Effectiveness.

Any measures implemented to address safety concerns identified during a specific time frame.

Safety concerns are monitored in relation to post-marketing experience.

Suspected Unexpected Serious Adverse Reaction.

New signals that emerge, remain ongoing, or are closed during the reporting period.

The positive effects in relation to risks related to quality, safety, or efficacy concerning patient or public health.

Pharmacovigilance system master file.

Effectiveness of Risk Minimisation (if applicable).

A dynamic document that should be updated throughout the life-cycle of the medicinal product.

Additional approved uses of a product beyond its primary indication.

Periodic Safety Update Report.

Literature.

Information suggesting a new potentially causal association or a new aspect of a known association between an intervention and an event.

World Health Organization.

WHO Drug Dictionary.

eXtended EudraVigilance Medicinal Product Dictionary.

It relates to safety findings impacting medications composed of multiple active ingredients.

Periodic Benefit-Risk Evaluation Reports.

Key results and safety findings observed during the reporting period.

They summarize adverse events reported after a drug has been marketed.

Observations and experiments.

Monitoring subjects for extended periods after trial completion to assess long-term effects.

Development Safety Update Report.

Non-clinical Data.

Lack of Efficacy in Controlled Clinical Trials.

Overview of Signals: New, Ongoing, or Closed.

Benefit Evaluation.

Adverse Event.

Adverse Drug Reaction.