Baseline characteristics
Factors that describe study participants at the beginning of the study (e.g., age, sex, disease severity). In comparison studies, it is importantthat these characteristics be initially similar between groups; if…
Factors that describe study participants at the beginning of the study (e.g., age, sex, disease severity). In comparison studies, it is importantthat these characteristics be initially similar between groups; if…
A statistical method for making comparisons between groups, whiletaking into account different variables measured at the start of atrial. It is a form of multiple regression. Source: (CIOMS VI: Clinical…
An identified risk associated with the use of medicinal products which requires urgent measures to protect patients. Source: (CIOMS VIII: Signal detection 2010)
A tool that assesses the methodological rigour and transparency in which a guideline is developed. Source: (CIOMS XI: Patient involvement 2022)
The clinical trial industry is constantly evolving, with electronic Trial Master Files (eTMF) becoming increasingly popular among sponsors and CROs. By reducing the need for paper documents and streamlining processes,…
In this white paper, we explore the regulatory requirements, processes, and best practices related to creating certified copies of original documents within an eTMF system.
Navigating the complex world of electronic Common Technical Document (eCTD) submissions to the FDA can be a daunting task. Ensuring compliance with FDA regulations and avoiding potential pitfalls is crucial…
As a leading software company that provides innovative solutions to the life sciences, healthcare, and other regulated industries, we at Ennov understand the importance of maintaining a high level of…
One of 5 dimensions in the RE-AIM evaluation model (Reach, Efficacy, Adoption, Implementation, Maintenance). Adoption refers to the participation rate and representativeness of both the settings in which an intervention…
A risk minimisation measure which is in addition to the routine risk minimisation activities which apply to all medicinal products in a particular region or territory. Synonyms: Additional risk minimisation…
A system for the collection of case safety information as a continuous pre-organized process. Active surveillance can be: Drug based: identifying adverse events in patients taking certain products; Identifying adverse…
The degree of risk (likelihood of an adverse event or outcome) that a person or group is prepared to take or considers reasonable. However, what may be acceptable for one…
The environment or community concerned with research, education, and scholarship. Source: (CIOMS XI: Patient involvement 2022)
The number of people in a group who experience an adverse effect divided by the number in that group who could experience that adverse effect. Source: (CIOMS VI: Clinical trial…
Ennov's regulatory and quality offers have registered excellent results, positioning the company as one of the world's leaders. The orders should enable another year of profitable growth. Ennov has greatly…
As clinical trial complexity increases, life sciences companies must have a technology strategy that supports research, development, and commercial business units. A recent Gartner report, "Navigate a Path to Digital…
Horiba leverages a DMS to standardize workflows, eliminate paper, reduce time spent searching for information, and improve collaboration between departments.
The pharmaceutical industry plays a critical role in ensuring the health and well-being of people all over the world. With this important responsibility, it is essential for Life Science companies…
Learn how Maincare is leveraging Ennov Doc and the Ennov REST API to include document management capabilities in their products.
Learn how Ennov RIM can help streamline regulatory processes and improve data quality.
Regulatory Webinar Why SMBs should choose a right-sized RIM Are you in late phase development or have you just received approval for your product?See how a RIM system can maximize…
Healthcare and Life Science CIOs are facing mounting pressures to manage costs, optimize resources, and deliver value in an environment characterized by competing priorities and internal politics. A recent report…
Sponsor oversight of TMFs is a critical regulatory requirement for clinical trials, but it can be challenging to know where to start. In this on-demand webinar, interviews from a panel…
As a Life Sciences professional, finding the right vendor for your integrated document management, learning management, and quality management systems (QMS) is a critical decision. With so many options available,…
Maximize your eTMF efficiency, minimize your effort and risk: Attend our webinar to learn how! Wednesday, March 29th, 2023, 2pm EDT
Webinar Unlock The Full Potential of Product Development with EDMS Streamline processes and break down silos to reduce time to market! Tuesday, March 7th, 2023, 2pm EST Save my seat…
The life sciences industry is at the brink of a digital transformation, with economic pressures and disruptive technology and innovation challenging traditional business models. A recent Gartner® report entitled Predicts…
Ennov is pleased to announce that we are sponsoring the Trial Master File Summit being held in West Palm Beach, FL on March 20-22, 2023. The event welcomes Life science professionals from…
Ennov is pleased to announce that we will be exhibiting at the 2023 DIA Regulatory Submissions, Information and Document Management (RSIDM) Forum being held at the Bethesda North Marriott Hotel and Conference…
Why should you consider a Regulatory Platform instead of a standalone RIM solution? In less than 30 minutes, learn first steps, realistic objectives, and business benefits.
Electronic Data Capture (EDC) has become an essential part of clinical trials, providing a more efficient way to collect, manage and analyze data. Mobile EDC applications, which can be run…
Ennov assisted a valued Animal Health customer of almost 20 years in moving PV operations from a local installation to a new SaaS cloud environment. The result: An extremely smooth…
Perhaps no aspect of Regulatory Information Management (RIM) is more complicated than CMC changes. A wide variety of stakeholders are involved, from manufacturing/supply change to corporate quality to regulatory affairs…
Ennov, a provider of innovative software solutions for the life sciences industry, is pleased to announce the release of version 9.4 of its unified compliance platform. The latest version includes…
A set of pharmacovigilance activities and interventions designed to identify, characterise, prevent or minimise risks relating to medicinal products, including the assessment of the effectiveness of those activities and interventions.
The legal authority that is responsible for regulating all matters relating to drugs and medicinal products (e.g.: EMA, FDA, MHRA)
Pharmacovigilance document intended to provide an evaluation of the risk-benefit balance of a medicinal product for submission by marketing authorisation holders at defined time points during the post-authorisation phase.
The date of the first marketing authorisation for any product containing the active substance granted to any company in any country in the world.
Comprehensive, thoughtful annual review and evaluation of pertinent safety information collected during the reporting period related to a drug under investigation, whether or not it is marketed
Date of approval of the first authorization for conducting an interventional clinical trial in any country. Determines the start of regulatory requirement. The first data lock point for the DSUR…
Definition according to GVP Annex I (Rev 3): An identified risk or potential risk that could have an impact on the risk-benefit balance of the product or have implications for…
Definition according to GVP Annex I (Rev 3):An untoward occurrence for which there is some basis for suspicion of an association with the medicinal product of interest but where this…
Definition according to GVP Annex I (Rev 3):An untoward occurrence for which there is adequate evidence of an association with the medicinal product of interest. Explanatory wording provided in GVP…
Temporal relationship is considered positive if the event occurred during the use of the drug and/or within a plausible range based on the half-life of the drug. Categories for temporal…
The term ‘severe’ must not be confused with ‘serious’. In the English language, ‘severe’ is used to describe the intensity (severity) of a specific event (mild, moderate or severe); the…
Persistent or sporadic, intentional excessive use of medicinal product, which is accompanied by harmful physical or psychological effects.
A SUSAR is a serious ADR whose nature or severity is unexpected based on the applicable product information.
An adverse reaction, the nature, severity or outcome of which is not consistent with the applicable product information. Any event that is not expected, in accordance with the label (USPI…
Unintended effect occurring at normal dose related to the pharmacological properties.
An international classification of drugs providing the names and active ingredient of medicinal products used in different countries.
Dictionary meant for rational coding of adverse reaction terms, maintained by the Uppsala Monitoring Centre (UMC), the World Health Organization Collaborating Centre for International Drug Monitoring.
It sets out the agreed usage of the drug in the USA and provides information for healthcare professionals on the drug’s usage, efficiency and safety. This is part if the…
An adverse reaction whose nature, severity, specificity, or outcome is not consistent with the description given in product labelling or market authorization (USPI in the US, SmPC in Europe).
A (augmented): common dose-related reaction, related to a pharmacological action of the drug, predictable and with low mortality.B (bizarre): uncommon non-dose-related reaction, not related to a pharmacological action of the…
Reporting of AE cases by health professionals and pharmaceutical companies which does not derive from a study or any organized data collection scheme (i.e. is not solicited). Stimulated reporting Reporting…
Reports derived from organized data collection systems, including: Clinical trialsClinical registriesPost-approval patient use programsPatient support programsPatient disease management programsSurveys of patients or healthcare providersInformation on efficacy or patient compliance
Evaluation of the data supporting a detected signal to verify that there is sufficient evidence demonstrating a new potentially causal association, or a new aspect of a known association.
A set of activities performed to determine whether there are signals associated with medicinal product (based on ICSRs, data from active surveillance systems or studies, literature information, etc.) including: Signal…
Reported information on a new possible causal relationship (or a new aspect of a known relationship) between an adverse event and a drug. A signal is considered important and warrants…
This part of an RMP provides a synopsis of a medicinal product’s safety. It should be a summary of: The important identified risksImportant potential risksMissing information It should also address:…
An important identified risk, important potential risk or important missing information. Medicinal product safety concerns are identified, characterized, and monitored in the DSUR, RMP and PSUR.
Evidence of an absence of harm (not absence of evidence of harm). Judgement about safety takes into account the degree to which a given risk is acceptable.
Non-profit consortium formed between the US FDA, industry, academia and the Wellcome Trust to identify genetic variants associated with SAEs.
results in deathrequires patient hospitalizationresults in persistent or significant disability or incapacityis life-threateningor is a congenital anomaly/birth defect.“Severe” describes the intensity of an event (mild, moderate or severe), the event…
Product informationHealthcare professional communications / educational materialsPatient communications / educational materials
MAHs must prepare an RMP (Risk Management Plan) to implement the risk management system.
Activity that aims to ensure that the benefits of a medicinal product exceed the risks by the greatest achievable margin, by increasing the benefits or reducing the risks in three…
The probability of developing an outcome (refers normally but not always to a negative outcome). Absolute risk or Incidence Rate: The observed or calculated probability of the occurrence of an event in a…
Risk in a population of unexposed persons. It can be measured over time (incidence) or at a given time (prevalence).
Therapeutic practice where drugs are prescribed and used appropriately for the indication and the patient’s specific characteristics.
The proportion of total cases in a population at a particular time and a descriptive statistic, rather than a measurement of risk.
System created to monitor adverse drug events for identified patients receiving a specified drug (prescribers are requested to report all events, suspected adverse or not).
Aspects of the patient’s history which might explain reported adverse events (genetic, other drugs, disease history…).
The study of drug use and effects after release into the market.
A system used by an organization to comply with pharmacovigilance regulations and designed to monitor the safety of authorized medicinal products.
A compilation of information, maintained by the MAH. containing a detailed description of the pharmacovigilance system they use, available to competent authorities upon request.
The science and activities relating to the detection, assessment, understanding, and prevention of adverse effects or any other drug-related problem, in order to: Prevent harm from ADRs in humans arising…
The study of the use and effects of drugs in large numbers of people using an epidemiological approach
Study relating to an authorized medicinal product conducted with the aim of studying a safety hazard, confirming the safety profile of the product, or evaluating risk management measures.
Administration of a quantity of a medicinal product above the maximum recommended dose allowed by the authorized product information.
Situations where a medicinal product is intentionally used for a medical purpose not in accordance with the marketing authorization. For instance, medicine used: For disease that it is not approved…
An Odds is the probability of an occurrence divided by the probability of its non-occurrence. The Odds ratio is the ratio of the Odds between two populations.
Number of individuals needed to be treated for some specified period in order that one person would have one harmful event.
Medication errors with high potential for causing harm but did not (cancelled before reaching a patient or reaching the patient but who did not have untoward consequences).
Regulatory authority within a country with the clinical and scientific expertise to collect, analyze and advise on drug safety.
Potentially clinically significant gap in knowledge about the safety of a medicinal product for a specific patient population or concerning certain anticipated utilization (for instance long term use). Typical examples…
An identifiable reporter, patient, event and a suspect medicinal product are required for reporting cases of suspected adverse events.
Any mistake in the way a medication is taken or administered (prescription, storage, dispensing, preparation, administration…), that has the potential to harm the patient. Medication errors are outside the use…
Any reaction not mentioned in the official approved product information is unlabeled (otherwise it is termed labelled).
The rate of new cases of an outcome occurring per number of known at risk or exposed; and is a measurement of risk.
MedDRA includes a term list of important medical events (available on the EMA website), which aims to facilitate the classification of suspected ADRs, data analysis and the assessment of ICSRs.
International Conference on Harmonization of Technical Requirements for the Registration of Pharmaceuticals.
The nature and extent of actual damage that can be caused by a drug. Damage is measured by frequency of occurrence, severity or duration.
The EMA has issued these guidelines for the conduct of pharmacovigilance in the EU for human medical products.