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Study of pharmaceutical drug safety
Pharmacovigilance (PV, or PhV), also known as drug safety, is the discipline within pharmaceutical science that addresses the identification, evaluation
Pharmacovigilance
EU healthcare profession
In the European Union, the Qualified Person Responsible For Pharmacovigilance (QPPV) is an individual, usually an employee of a pharmaceutical company
Qualified Person Responsible For Pharmacovigilance
Qualified_Person_Responsible_For_Pharmacovigilance
The International Society of Pharmacovigilance (ISoP), previously the European Society of Pharmacovigilance (ESoP), is an international non-profit scientific
International Society of Pharmacovigilance
International_Society_of_Pharmacovigilance
The Society of Pharmacovigilance, India (SoPI), is an Indian national non-profit scientific organisation, which aims at organizing training programmes
Society of Pharmacovigilance, India
Society_of_Pharmacovigilance,_India
Agency of the European Union
the Pharmacovigilance Risk Assessment Committee (PRAC) has come into function in 2012 with the implementation of the new EU pharmacovigilance legislation
European_Medicines_Agency
Government regulatory agency
The Pharmacovigilance Programme of India (PvPI) is an Indian government organization which identifies and responds to drug safety problems. Its activities
Pharmacovigilance Programme of India
Pharmacovigilance_Programme_of_India
(FEDRA), also known as the Spanish Pharmacovigilance Datatabase or Spanish Pharmacovigilance System, is a pharmacovigilance database in Spain which was developed
Farmacovigilancia Española, Datos de Reacciones Adversas
Farmacovigilancia_Española,_Datos_de_Reacciones_Adversas
Type of offshore business entity
support, engineering, pharmaceutical marketing, clinical trials, pharmacovigilance, medical and regulatory affairs, health informatics, and health research
Global_capability_centre
Pharmaceutical symbol used in the UK
this time the black triangle label may or may not be discontinued. Pharmacovigilance EudraVigilance Uppsala Monitoring Centre (WHO) British National Formulary
Black triangle (pharmacovigilance)
Black_triangle_(pharmacovigilance)
European Medicines Agency committee
referral procedures. The CHMP considers recommendations from the Pharmacovigilance Risk Assessment Committee (PRAC) on the safety of medicines already
Committee for Medicinal Products for Human Use
Committee_for_Medicinal_Products_for_Human_Use
Science studying the uses and effects of drugs in populations
that are altogether unique to pharmacoepidemiology, e.g., pharmacovigilance. Pharmacovigilance is a type of continual monitoring of unwanted effects and
Pharmacoepidemiology
Veterinary pharmacovigilance in the United Kingdom is overseen by the Veterinary Medicines Directorate (VMD). The Pharmacovigilance Unit at the VMD monitors
Veterinary pharmacovigilance in the United Kingdom
Veterinary_pharmacovigilance_in_the_United_Kingdom
treatment choices made and observed outcomes. Shah's early analysis of pharmacovigilance using electronic medical records has demonstrated that it is possible
Nigam_Shah
Medical research centre in Sweden
assessing and communicating information from member countries' national pharmacovigilance centres in regard to the risks of medicines and vaccines. Since 1978
Uppsala_Monitoring_Centre
Clinical trials management company
Asset Management. In 2026, Parexel acquired Vitrana, an AI-powered pharmacovigilance platform provider, to expand its patient safety technology capabilities
Parexel
Chemical compound
Atosiban, sold under the brand name Tractocile among others, is an inhibitor of the hormones oxytocin and vasopressin. It is used as an intravenous medication
Atosiban
Academic journal
a peer-reviewed medical journal covering pharmacoepidemiology and pharmacovigilance. It was established in 1986 as Medical Toxicology, and was renamed
Drug_Safety
Indian pharmacologist (born 1972)
Medical College, Aligarh, Elected Secretary of IAOMC and Society of Pharmacovigilance, India (SoPI). Syed Ziaur Rahman's father Hakim Syed Zillur Rahman
Syed_Ziaur_Rahman
Medication legally requiring a medical prescription before it can be dispensed
Investigational New Drug Clinical trial phases Randomized controlled trial Pharmacovigilance Abbreviated New Drug Application Fast track approval Off-label use
Prescription_drug
Company that is paid to provide research
commercialization, clinical development, clinical trials management, pharmacovigilance, outcomes research, and real world evidence. CROs are designed to
Contract research organization
Contract_research_organization
South Asian Greco-Arabic traditional medicine
poisonous. The Indian Journal of Pharmacology notes: According to WHO, "Pharmacovigilance activities are done to monitor detection, assessment, understanding
Unani_medicine
Biomedical and pharmacological database
published literature designed to support information managers and pharmacovigilance in complying with the regulatory requirements of a licensed drug.
Embase
Indian multinational company
provides consulting in pharmaceutical marketing, clinical trials, pharmacovigilance, medical and regulatory affairs, and health informatics. Indegene
Indegene
Contract research organization
project management, monitoring, data management and biostatistics, pharmacovigilance, medical writing, and mobile clinical services. It focuses on oncology
Fortrea
Cause of death by drug overdose from poly drug use
deaths from drug overdose and intoxication Adverse drug reaction Pharmacovigilance "Polydrug Abuse - Dangerous Drug Combinations". AddictionCenter. Retrieved
Combined_drug_intoxication
Clinical research to establish the characteristics of COVID-19 vaccines
COVID-19 vaccine clinical research uses clinical research to establish the characteristics of COVID-19 vaccines. These characteristics include efficacy
COVID-19 vaccine clinical research
COVID-19_vaccine_clinical_research
CIA program involving illegal experimentation on human test subjects (1953–1972)
rehabilitation Needle and syringe programmes Opioid replacement therapy Pharmacovigilance Reagent testing Regulation of therapeutic goods Responsible drug use
MKUltra
Chemical compound
used as a cutting agent in illegal cocaine. In February 2026, the Pharmacovigilance Risk Assessment Committee of the European Medicines Agency recommended
Levamisole
Species of plant
and Natural Products: Its Significance for Pharmacovigilance". In Joanne Barnes (ed.). Pharmacovigilance for Herbal and Traditional Medicines Advances
Rosemary
USFDA program and procedures
Investigational New Drug Clinical trial phases Randomized controlled trial Pharmacovigilance Abbreviated New Drug Application Fast track approval Off-label use
Investigational_New_Drug
rehabilitation Needle and syringe programmes Opioid replacement therapy Pharmacovigilance Reagent testing Regulation of therapeutic goods Responsible drug use
Legal status of psychedelic drugs in the United Kingdom
Legal_status_of_psychedelic_drugs_in_the_United_Kingdom
Medication for pain and fever
necrolysis, Rechallenge tests and an analysis of American but not French pharmacovigilance databases indicated a risk of these reactions. In clinical trials
Paracetamol
Application for US generic drug approval
Investigational New Drug Clinical trial phases Randomized controlled trial Pharmacovigilance Abbreviated New Drug Application Fast track approval Off-label use
Abbreviated New Drug Application
Abbreviated_New_Drug_Application
Indian pharmacologist (1941–2025)
of Indian Pharmacovigilance and organised many scientific meets in the field of Pharmacovigilance. He founded the Society of Pharmacovigilance, India (SoPI)
Krishan_Chandra_Singhal
Academic journal
peer-reviewed medical journal publishing review articles on all aspects of pharmacovigilance and original papers on the clinical implications of drug treatment
Expert_Opinion_on_Drug_Safety
Good practice guidelines and regulations
microbiological practice, or GMiP Good participatory practice, or GPP Good pharmacovigilance practice, or GPvP or even GVP Good pharmacy practice, or GPP Good
Good_practice
Loop diuretic medication
independent risk attributable to furosemide remains uncertain. A 2025 pharmacovigilance study suggested that hearing disturbances associated with furosemide
Furosemide
Harmful, unintended response to medications
the drug. The study of ADRs is the concern of the field known as pharmacovigilance. An adverse event (AE) refers to any unexpected and inappropriate
Adverse_drug_reaction
rehabilitation Needle and syringe programmes Opioid replacement therapy Pharmacovigilance Reagent testing Regulation of therapeutic goods Responsible drug use
Drug_policy_of_China
Antifungal medication
and hearing loss have been reported in rare cases. The Netherlands Pharmacovigilance Centre Lareb and WHO's global VigiBase database both reported multiple
Terbinafine
dealing with the topics of pharmacoepidemiology in the context of pharmacovigilance or drug safety; the International Society for Pharmacoeconomics and
International Society for Pharmacoepidemiology
International_Society_for_Pharmacoepidemiology
Topics referred to by the same term
through/via the vagina Periventricular nucleus, of the hypothalamus Pharmacovigilance, a science of pharmaceutical products Poliovirus, the causative agent
PV
SSRI antidepressant
reports, after escitalopram. In 2019, the European Medicines Agency's Pharmacovigilance Risk Assessment Committee (PRAC) recommended that product labels for
Citalopram
rehabilitation Needle and syringe programmes Opioid replacement therapy Pharmacovigilance Reagent testing Regulation of therapeutic goods Responsible drug use
List_of_drug_combinations
rehabilitation Needle and syringe programmes Opioid replacement therapy Pharmacovigilance Reagent testing Regulation of therapeutic goods Responsible drug use
Organised_crime_in_Colombia
Pseudoscientific alternative medicine originating from India
915. PMC 2755247. PMID 18728265. Urmila, T.; Supriya, B. (2008). "Pharmacovigilance of ayurvedic medicines in India". Indian Journal of Pharmacology.
Ayurveda
rehabilitation Needle and syringe programmes Opioid replacement therapy Pharmacovigilance Reagent testing Regulation of therapeutic goods Responsible drug use
Methamphetamine in the United States
Methamphetamine_in_the_United_States
SSRI antidepressant
sexual problems suggest that the incidence is >70%. In 2019, the Pharmacovigilance Risk Assessment Committee of the European Medicines Agency recommended
Fluoxetine
International non-governmental medical science organization
for Regulatory Activities (MedDRA) Queries (founded 2002) Vaccine Pharmacovigilance (founded November 2005) Working Group VIII (founded September 2006):
Council for International Organizations of Medical Sciences
Council_for_International_Organizations_of_Medical_Sciences
Monoclonal antibody
recumbency, urinary incontinence, polyuria, and polydipsia. A global pharmacovigilance reporting of the first monoclonal antibody for canine osteoarthritis
Bedinvetmab
Anti-inflammatory drug
(2004). "A Case Report on Nimesulide and its Relation with Angina". J Pharmacovigilance Drug Safety. 1: 19–21. Khan RA, Rahman SZ (2004). "Nimesulide Induced
Nimesulide
Hospital
(born 1949), clinical pharmacologist, former dean of KEM, Known for pharmacovigilance, drug development, tropical diseases, drug resistance, and medical
Seth G.S. Medical College and King Edward Memorial Hospital
Seth_G.S._Medical_College_and_King_Edward_Memorial_Hospital
US public health issue
rehabilitation Needle and syringe programmes Opioid replacement therapy Pharmacovigilance Reagent testing Regulation of therapeutic goods Responsible drug use
United States drug overdose death rates and totals over time
United_States_drug_overdose_death_rates_and_totals_over_time
Beta-1 selective adrenenergic blocker medication used to treat cardiovascular diseases
cardioselective β1-blockers in asthma: literature review and search of global pharmacovigilance safety reports". ERJ Open Research. 7 (1). doi:10.1183/23120541.00801-2020
Bisoprolol
Pharmacovigilance system in the United Kingdom
international standard format. EudraVigilance (European Medicines Agency) Pharmacovigilance Uppsala Monitoring Centre (World Health Organization) Vaccine Adverse
Yellow_Card_Scheme
Anxiolytic medication
of misuse or dependence with etifoxine were identified in a French pharmacovigilance survey, which is also in contrast to benzodiazepines. Etifoxine has
Etifoxine
Medication
were introduced in 1985. In the early 1980s signs began to emerge in pharmacovigilance studies from Sweden that the drug was causing tardive dyskinesia in
Metoclopramide
marketing authorisation applications by pharmaceutical companies; The pharmacovigilance of products on the market to ensure the maintenance of high standards
EUDRANET
SNRI antidepressant
the agent is discontinued. In 2019, the European Medicines Agency's Pharmacovigilance Risk Assessment Committee recommended that product labels for all
Venlafaxine
Peripheral D2 receptor antagonist
domperidone-containing medicines. It also approved earlier published suggestions by Pharmacovigilance Risk Assessment Committee (PRAC) to use domperidone only for treating
Domperidone
Subgenre of comedy films
rehabilitation Needle and syringe programmes Opioid replacement therapy Pharmacovigilance Reagent testing Regulation of therapeutic goods Responsible drug use
Stoner_film
EudraVigilance Institutional review board Monitoring in clinical trials Pharmacovigilance Rawat, Nand Kishore; Kerr, David (2023). Data Monitoring Committees
Data_monitoring_committee
Retail outlet selling hallucinogenic mushroom products
rehabilitation Needle and syringe programmes Opioid replacement therapy Pharmacovigilance Reagent testing Regulation of therapeutic goods Responsible drug use
Psychedelic_mushroom_store
reports from the Adverse Drug Reactions Unit (now a function of the Pharmacovigilance Branch) of the Therapeutic Goods Administration (TGA), which administers
Adverse Drug Reactions Advisory Committee
Adverse_Drug_Reactions_Advisory_Committee
Prominent street drug scientist, epidemiologist, and harm reduction advocate
helped develop mobile apps and social media analysis technology for pharmacovigilance to enhance greater patient participation in pharmaceutical regulation
Nabarun_Dasgupta
US law
Investigational New Drug Clinical trial phases Randomized controlled trial Pharmacovigilance Abbreviated New Drug Application Fast track approval Off-label use
Drug Price Competition and Patent Term Restoration Act
Drug_Price_Competition_and_Patent_Term_Restoration_Act
EU laws on medicinal products
Veterinary use: Volume 4 - Good Manufacturing Practices. Volume 9 - Pharmacovigilance. Miscellaneous: Guidelines on Good Distribution Practice of Medicinal
EudraLex
rehabilitation Needle and syringe programmes Opioid replacement therapy Pharmacovigilance Reagent testing Regulation of therapeutic goods Responsible drug use
Drug_policy_of_South_Korea
Opioid medication
rehabilitation Needle and syringe programmes Opioid replacement therapy Pharmacovigilance Reagent testing Regulation of therapeutic goods Responsible drug use
Oxycodone
Nonsteroidal anti-inflammatory drug (NSAID; analgesic)
restrictions on dose and duration of treatment". Current Problems in Pharmacovigilance. 19: 5–6. Klemko R. "Toradol Lawsuit: NFL Can't Outrun Legacy of Abuse"
Ketorolac
Medical monitoring
released on the market and is an important part of the science of pharmacovigilance. Since drugs and medical devices are approved on the basis of clinical
Postmarketing_surveillance
Use of an excessive amount of a drug
rehabilitation Needle and syringe programmes Opioid replacement therapy Pharmacovigilance Reagent testing Regulation of therapeutic goods Responsible drug use
Drug_overdose
EudraVigilance (European Union Drug Regulating Authorities Pharmacovigilance) is the European data processing network and management system for reporting
EudraVigilance
Psychoactive drug, often called ecstasy
rehabilitation Needle and syringe programmes Opioid replacement therapy Pharmacovigilance Reagent testing Regulation of therapeutic goods Responsible drug use
MDMA
Profound state of unease or dissatisfaction
rehabilitation Needle and syringe programmes Opioid replacement therapy Pharmacovigilance Reagent testing Regulation of therapeutic goods Responsible drug use
Dysphoria
Topics referred to by the same term
Farmacovigilancia Española, Datos de Reacciones Adversas, a Spanish pharmacovigilance database FedRAMP, a United States based cyber security program Fedratinib
FEDRA
Dissociative anesthetic and anti-depressant
rehabilitation Needle and syringe programmes Opioid replacement therapy Pharmacovigilance Reagent testing Regulation of therapeutic goods Responsible drug use
Ketamine
Prohibition of drugs through law
rehabilitation Needle and syringe programmes Opioid replacement therapy Pharmacovigilance Reagent testing Regulation of therapeutic goods Responsible drug use
Drug_prohibition
Class of recreational drugs
rehabilitation Needle and syringe programmes Opioid replacement therapy Pharmacovigilance Reagent testing Regulation of therapeutic goods Responsible drug use
Designer_drug
Mushrooms containing psychoactive indole alkaloids
rehabilitation Needle and syringe programmes Opioid replacement therapy Pharmacovigilance Reagent testing Regulation of therapeutic goods Responsible drug use
Psilocybin_mushroom
the approval and registration of new medication in Belgium and for pharmacovigilance. Hugues Malonne is the CEO of the agency. The agency succeeded the
Federal Agency for Medicines and Health Products
Federal_Agency_for_Medicines_and_Health_Products
International medical terminology dictionary-thesaurus
(clinical research phase 0 to phase 3) to post-marketing activities (pharmacovigilance or clinical research phase 4), and for safety information data entry
MedDRA
American nonprofit organization
rehabilitation Needle and syringe programmes Opioid replacement therapy Pharmacovigilance Reagent testing Regulation of therapeutic goods Responsible drug use
Council on Spiritual Practices
Council_on_Spiritual_Practices
Drug that increases alertness
rehabilitation Needle and syringe programmes Opioid replacement therapy Pharmacovigilance Reagent testing Regulation of therapeutic goods Responsible drug use
Stimulant
Intense feelings of well-being
rehabilitation Needle and syringe programmes Opioid replacement therapy Pharmacovigilance Reagent testing Regulation of therapeutic goods Responsible drug use
Euphoria
European pharmaceutical research initiative
European Medicines Research Training Network Eu2P: European programme in Pharmacovigilance and Pharmacoepidemiology Pharmatrain: Pharmaceutical Medicine Training
Innovative Health Initiative Joint Undertaking
Innovative_Health_Initiative_Joint_Undertaking
Medication
correspondence published online in February 2019. In April 2019, the Pharmacovigilance Risk Assessment Committee (PRAC) of the European Medicines Agency
Alemtuzumab
Inhalation of nitrous oxide for psychoactive effects
rehabilitation Needle and syringe programmes Opioid replacement therapy Pharmacovigilance Reagent testing Regulation of therapeutic goods Responsible drug use
Recreational use of nitrous oxide
Recreational_use_of_nitrous_oxide
Group of tetraterpenes
by other retinoids, bexarotene causes severe hypothyroidism. The Pharmacovigilance Risk Assessment Committee (PRAC), based on its review, confirmed that
Retinoid
SSRI antidepressant
majority of reported cases. In 2019, the European Medicines Agency's Pharmacovigilance Risk Assessment Committee (PRAC) recommended that product labels for
Sertraline
Psychedelic drug
rehabilitation Needle and syringe programmes Opioid replacement therapy Pharmacovigilance Reagent testing Regulation of therapeutic goods Responsible drug use
LSD
rehabilitation Needle and syringe programmes Opioid replacement therapy Pharmacovigilance Reagent testing Regulation of therapeutic goods Responsible drug use
Treatment and management of addiction
Treatment_and_management_of_addiction
Legal management of drugs and restricted substances
manufacturing practice (GMP), good distribution practice (GDP), and good pharmacovigilance practice (GVP). EU legislation requires that each Member State operates
Regulation of therapeutic goods
Regulation_of_therapeutic_goods
British statistician
safety and to efforts by WHO to create an international system of pharmacovigilance. In 2002 he returned to contact with the Uppsala Monitoring Centre
D._J._Finney
Nonprofit educational organization
also sometimes serves as a mechanism of postmarket surveillance or pharmacovigilance in the realm of illicit and experimental substances. The Hive (website)
Erowid
rehabilitation Needle and syringe programmes Opioid replacement therapy Pharmacovigilance Reagent testing Regulation of therapeutic goods Responsible drug use
List of countries by annual cannabis use
List_of_countries_by_annual_cannabis_use
Medical condition
rehabilitation Needle and syringe programmes Opioid replacement therapy Pharmacovigilance Reagent testing Regulation of therapeutic goods Responsible drug use
Substance_abuse
International Society of Pharmacoepidemiology International Society of Pharmacovigilance International Union of Basic and Clinical Pharmacology Medical Women's
List_of_medical_organisations
Class of medication used to treat depression and other conditions
withdrawal (EPITT no 19277), 11 June 20191, EMA/PRAC/265221/2019, Pharmacovigilance Risk Assessment Committee (PRAC) Sansone RA, Sansone LA (October 2010)
Antidepressant
Autoimmune disease in which the immune system attacks healthy tissue
revisiting the ever-changing spectrum of the disease using the WHO pharmacovigilance database". Annals of the Rheumatic Diseases. 78 (4): 504–508. doi:10
Lupus
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