inbound2191348902441231505

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.

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

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

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

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

Good pharmacovigilance practice (GVP) guidelines.

Direct Healthcare Professional Communication.

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

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

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

Programs that allow individual patients access to unapproved therapies.

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

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

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

Development International Birth Date.

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

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

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

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

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

Physicians, nurses, pharmacists, etc.

It contributes to the protection of patient and public health.

Uppsala Monitoring Centre.

Data Lock Point.

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

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

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

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

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

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

The entire life-cycle of a medicinal product.

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

Designated Medical Event.

United States Food and Drug Administration (USFDA).

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

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

Adverse Drug Reaction.

An adverse reaction inconsistent with the applicable product information.

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

Suspected Unexpected Serious Adverse Reaction.

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

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.

Development Safety Update Report.

Medicines and Healthcare Regulatory Agency (MHRA).

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

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

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.

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

Adverse Event.

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

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

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

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

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

Electronic Common Technical Document.

Ministry of Health, Labour and Welfare (MHLW).

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

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

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

The international reporting form.

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

Adverse event following immunization.

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

Regulation (EC) No 1394/2007.

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

Important medical event.

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

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

The study of different doses of medication.

Electronic Reaction Monitoring Report.

Therapeutic Goods Administration (TGA).

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

Council for International Organizations of Medical Sciences.

Requirements, procedures, roles, and activities in pharmacovigilance.

EU Reference Date.

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

Periodic safety update reports manual.

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

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

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

Adverse event of special interest.

International non-proprietary name.

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.

Different groups of patients receiving medication.

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

Periodic Reporting.

7 days.

European Economic Area.

Central Drugs Standard Control Organization (CDSCO).

Lack of efficacy/effect.

Uppsala Monitoring Centre (UMC).

Marketing Authorisation Holders (MAH) and Competent Authorities.

EV.

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

Core data sheets.

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

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

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

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

Chronically or seriously debilitating diseases and life-threatening diseases.

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

Additional risk minimization measure.

Marketing authorisation.

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

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

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

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

Preferred term.

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

15 days.

European Medicines Agency.

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

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

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

EudraVigilance Clinical Trial Module.

Benefit-risk assessments.

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

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

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

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

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

Marketing authorisation holder.

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

Advanced therapy medicinal product.

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

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

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

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

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

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

Qualified Person responsible for Pharmacovigilance.

Developmental International Birth Date.

90 days.

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

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

European Public Assessment Report.

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

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

A set of measures to facilitate pharmacovigilance in the EU.

EudraVigilance Data Analysis System.

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

Practical issues in Pharmacovigilance.

Further analysis of the detected signal.

The date designated based on the international birth date.

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

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

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

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

Medication error.

Prescribing, storage, dispensing, preparation, and administration.

Company core data sheet.

Quarterly.

Administering medicine by methods not approved for its use.

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

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

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

Randomised clinical trial.

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

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

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

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

European Pharmacovigilance Issues Tracking Tool.

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

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

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

EudraVigilance Expert Working Group.

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

Clinical trial safety data.

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

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

The date designated based on the development international birth date.

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.

Risk Evaluation and Mitigation Strategy.

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

Annually.

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

Medical Dictionary for Regulatory Activities.

Company core safety information.

The element of 'intention' at the prescriber level.

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

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

No, no additional procedures shall be applied.

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

Patterns of medication errors and potential medication errors.

Risk minimisation measure.

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

The first anniversary of the DIBD.

Healthcare professionals, patients, or consumers.

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

Periodic Safety Update Report.

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

European Union.

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

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

Yes, they cover centrally and nationally authorized medicines.

EudraVigilance Medicinal Product Dictionary.

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

Development safety update reports.

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