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Adverse Drug Reaction (ADR) - Adverse drug reactions, as established by regional regulations, guidance, and practices, concern noxious and unintended responses to a medicinal product. The phrase “responses to a medicinal product” means that a causal relationship between a medicinal product and an adverse event is at least a reasonable possibility (refer to the ICH E2A guideline).A reaction, in contrast to an event, is characterized by the fact that a causal relationship between the drug and the occurrence is suspected. For regulatory reporting purposes, if an event is spontaneously reported, even if the relationship is unknown or unstated, it meets the definition of an adverse drug reaction.
Adverse Event (AE, or Adverse Experience) - An adverse event is any untoward medical occurrence in a patient administered a medicinal product and which does not necessarily have to have a causal relationship with this treatment. An adverse event can therefore be any unfavourable and unintended sign (for example, an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to this medicinal product.
Benefit Risk Balance- balance of the overall benefit (to the patient, not to be confused with ‘efficacy’) and risk (risk based on all available information on medical products or group of products). The lower the benefit, the lower the risk tolerated.
Build, Operate, Xfer (BOX) – a Pharmacovigilance system which is devised or re-engineered with outsourced PV expertise and staff resources and then through knowledge transfer and training the company assumes responsibility for its day-to-day operations.
Causality – Documentation of causal relationship between a medicinal product and an AE/ADR; often referred to as Relatedness (‘suspected’). In clinical trials and for solicited cases, the investigator must provide an opinion on causality. If no causality is provided, the sponsor must f/u and can provide a preliminary causality assessment. Causality assessment determines need for expedited reporting.
Spontaneous post-marketing (unsolicited) cases have implied causality unless they can be DEFINITELY be excluded by the reporter.
Solicited reports on marketed products equire full causality assessment.
Post authorisation clinical trial cases are subject to full causality assessment.
For all cases requiring causality assessment it is considered best practice to assign causality as ‘positive’ unless causality has been ruled through follow up with the investigator/reporter. A company opinion should NEVER downgrade a reporting causality opinion but may upgrade a case.
Contract Safety Organisation (CSO) – Service provider which provides a full spectrum of lifecycle drug safety services covering pre-phase I till after the end of the lifecycle. This includes a complete offering of Specialist Services, such as PV system development, PV and Risk Management Strategy and Planning, as well as Operational Services such as case handling, regulatory reporting, aggregate reports, signal detection and ongoing surveillance and safety studies.
European Qualified Person for Pharmacovigilance (EEA QPPV) – based on Volume 9a of the European PV regulations. The EEA QPPV is required for every company submitting a marketing application or marketing medicinal products in at least one of the European Member states. The QPPV carries personal legal liability for PV regulatory compliance, and is responsible for the following:
Expectedness (labelled/unlabelled) - Unexpected Adverse Drug Reaction - An adverse reaction or event, where the nature or severity of which is not consistent with the applicable product information (e.g., Investigator's Brochure for an unapproved investigational medicinal product or the SmPC/national label for an authorised product). This should include overdose, pregnancy and Lack of Efficacy.
Expedited Reporting – Fast reporting of AEs/ADRs which meet certain criteria. The criteria for expedited reporting differ from country to country. As a general rule, all suspected unexpected (unlabelled) serious adverse reactions (SUSAR) need to be expedited for clinical trials and all serious cases should be expedited for post-marketing cases. Some countries require reporting of all serious adverse events, regardless the causality (not suspected) or labelledness (not expected).
Fast-track PV System – integrated customized drug safety systems which aligns sponsor needs with regulatory compliance in order to rapidly scale up value adding benefit risk management
Healthcare Professional - Healthcare professional is defined as a medically-qualified person such as a physician, dentist, pharmacist, nurse, coroner, or as otherwise specified by local regulations.
ICH - International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use is a joint initiative involving both regulators and research-based industry focusing on the technical requirements for medicinal products containing new drugs.
ICH Seriousness Criteria: A serious adverse event (experience) or reaction is any untoward medical occurrence that at any dose:
ICSR – Individual Case Safety Report – individual single case report on an adverse experience with a medicinal product.
Lack of Efficacy (LoE) - Lack of Efficacy reports should be classified as such and included in signal detection, benefit risk assessment and summary reports (eg. PSURs)
Lifecycle Drug Safety = Lifecycle Pharmacovigilance – new, integrative term, including all phases of drug safety from development phases through to post marketing.
Pharmacovigilance (PV) – traditionally the drug safety surveillance system for marketed medicinal products; in a more contemporary definition and in alignment with CIOMS VI, rather lifecycle drug safety including benefit-risk management, including scientific and data gathering activities relating to the detection, assessment, understanding, and prevention of adverse effects or any other product-related problems, including but not limited to the use of post-marketing surveillance methods.
Pharmacovigilance Organisation (PVO) – used as synonym of Contract Safety Organisation
Pharmacovigilance Strategy – strategy which helps companies to effectively and efficiently deliver high quality and compliant drug safety services
Pregnancy Safety Reporting - Pregnancy occurring drug administration, while not an adverse event, requires monitoring and follow up at term. Pregnancies are included in signal detection, benefit risk assessment and summary reports (eg.PSURs). In teratogenic drugs pregnancy reports should be expedited as serious. All pregnancy cases should be entered in a safety database and followed up until the outcome of the pregnancy is know (including data on the newborn).
PSUR – Periodic Safety Update Report – aggregate report which examines and summarise all existing safety experience with a medicinal product and which needs to be submitted to Health Authorities in predetermined intervals. Can be harmonized globally by adopting an International Birth Date (IBD). Report includes benefit risk assessment of SAEs and ADRs, pregnancy reports, overdose and Lack of Efficacy reports
PV Risk Management – integrated system which identifies, characterises, prevents or minimises risk to public health arising from investigational or marketed products.
PV Risk Management Plan – document required in differing formats by FDA and EMEA as part of the submission file for Market Authorisation. This document includes a Pharmacovigilance Plan and details risk minimisation activities.
PV Value Chain – integrated business system consisting of governance, people, process and technology which as an outcome delivers high quality, fully compliant PV functionality during the lifecycle of a product in support and alignment with the overall strategy
Risk Management – Corporate level: Integrative system which continuously analysis and mitigates business risks from all business section
Safety Surveillance – ongoing or targeted medical and scientific (including epidemiological) examination of information obtained on an investigational or marketed product including data mining (“signal detection”) using internal and external databases and electronic tools
Severity - To ensure no confusion or misunderstanding of the difference between the terms "serious" and "severe," which are not synonymous, the following note of clarification is provided: The term "severe" is often used to describe the intensity (severity) of a specific event (as in mild, moderate, or severe myocardial infarction); the event itself, however, may be of relatively minor medical significance (such as severe headache). This is not the same as "serious," which is based on patient/event outcome or action criteria usually associated with events that pose a threat to a patient's life or functioning. Seriousness (not severity) serves as a guide for defining regulatory reporting obligations.
Virtual Pharmacovigilance (VPV) – fully outsourced lifecycle drug safety services including strategy, risk management, ongoing surveillance and regulatory reporting to support pharmaceutical and biotech companies to effectively and efficiently manage the risk benefit balance of their investigational and marketed products at significant cost and strategic advantages