PRAC
E553849
PRAC is a committee within the European Medicines Agency responsible for assessing and monitoring the safety of human medicines.
All labels observed (1)
| Label | Occurrences |
|---|---|
| PRAC canonical | 2 |
How this entity was disambiguated
This entity first appeared as the object of triple T5872851 — resolving that mention is where its identity was fixed. The disambiguator weighed these candidate entities and picked the highlighted one (or “None”, minting a new entity). This is how homonymy is resolved: the same surface form can point to different entities.
NED1
Entity disambiguation (via context triple)
gpt-5-mini-2025-08-07
Target entity: PRAC Context triple: [Pharmacovigilance Risk Assessment Committee, abbreviation, PRAC]
-
A.
Praktikos
Praktikos is an early Christian ascetic treatise by Evagrius Ponticus that outlines practical guidance for monks on combating thoughts and cultivating virtue.
-
B.
PRTC
PRTC was a leftist Salvadoran guerrilla organization that became one of the constituent groups of the Farabundo Martí National Liberation Front (FMLN) during El Salvador’s civil war.
-
C.
PRTC
PRTC is a public transit agency serving Northern Virginia with commuter and local bus services.
-
D.
PRTC
PRTC stands for Primary Reference Time Clock, a highly accurate timing source used in telecommunications networks to provide traceable time and phase synchronization.
-
E.
PRA
PRA is the commonly used abbreviation for the Postal Reorganization Act of 1970, the U.S. federal law that transformed the Post Office Department into the United States Postal Service.
- F. None of above. chosen
- G. Unsure - the case is ambiguous/there is not enough information to decide.
NED2
Entity disambiguation (via description)
gpt-5-mini-2025-08-07
Target entity: PRAC Target entity description: PRAC is a committee within the European Medicines Agency responsible for assessing and monitoring the safety of human medicines.
-
A.
Praktikos
Praktikos is an early Christian ascetic treatise by Evagrius Ponticus that outlines practical guidance for monks on combating thoughts and cultivating virtue.
-
B.
PRTC
PRTC was a leftist Salvadoran guerrilla organization that became one of the constituent groups of the Farabundo Martí National Liberation Front (FMLN) during El Salvador’s civil war.
-
C.
PRTC
PRTC is a public transit agency serving Northern Virginia with commuter and local bus services.
-
D.
PRTC
PRTC stands for Primary Reference Time Clock, a highly accurate timing source used in telecommunications networks to provide traceable time and phase synchronization.
-
E.
PRA
PRA is the commonly used abbreviation for the Postal Reorganization Act of 1970, the U.S. federal law that transformed the Post Office Department into the United States Postal Service.
- F. None of above. chosen
Statements (45)
| Predicate | Object |
|---|---|
| instanceOf | pharmacovigilance committee ⓘ |
| abbreviationOf | Pharmacovigilance Risk Assessment Committee ⓘ |
| aim | to protect public health by ensuring the safe use of medicines ⓘ |
| composition |
independent scientific experts
ⓘ
members nominated by EEA-EFTA states ⓘ members nominated by EU Member States ⓘ representatives of healthcare professionals ⓘ representatives of patients and consumers ⓘ |
| country | Netherlands ⓘ |
| dateFormed | 2012 ⓘ |
| field |
drug safety
ⓘ
pharmacovigilance ⓘ public health ⓘ |
| formedAs | new committee under the 2010 EU pharmacovigilance legislation ⓘ |
| fullName | Pharmacovigilance Risk Assessment Committee ⓘ |
| hasRole |
advisory body to the European Medicines Agency Management Board
ⓘ
providing scientific opinions on safety issues ⓘ |
| jurisdiction | European Union ⓘ |
| language | English ⓘ |
| locatedIn |
Amsterdam
ⓘ
Netherlands ⓘ |
| meets | monthly ⓘ |
| parentOrganization | European Medicines Agency ⓘ |
| partOf | European Medicines Agency ⓘ |
| produces |
meeting highlights
ⓘ
recommendations on safety-related variations and suspensions ⓘ |
| regulatoryFramework |
Directive 2001/83/EC as amended by pharmacovigilance legislation
ⓘ
linked to:
European Union pharmaceutical legislation
EU pharmacovigilance legislation ⓘ Regulation (EC) No 726/2004 ⓘ |
| responsibleFor |
assessing the safety of human medicines
ⓘ
monitoring the safety of human medicines ⓘ periodic safety update report assessment ⓘ pharmacovigilance activities in the EU ⓘ pharmacovigilance inspections guidance ⓘ post-authorisation safety studies assessment ⓘ providing recommendations on safety-related regulatory actions ⓘ recommending risk minimisation measures for medicines ⓘ risk assessment of adverse drug reactions ⓘ safety-related aspects of risk management plans ⓘ signal detection and evaluation for medicinal products ⓘ |
| scope | human medicines ⓘ |
| website | https://www.ema.europa.eu/en/committees/pharmacovigilance-risk-assessment-committee-prac ⓘ |
| worksWith |
Committee for Medicinal Products for Human Use
ⓘ
Coordination Group for Mutual Recognition and Decentralised Procedures – Human ⓘ national competent authorities for medicines in EU and EEA ⓘ |
How these facts were elicited
The pipeline generated the facts above by prompting gpt-5.1 with this entity's name + description and the instruction below.
Instruction
You are a knowledge base construction expert. Given a subject entity and a description of it, return factual statements that you know for the subject as a JSON list of dictionaries(triples), where keys must be "subject", "predicate" and "object". The number of facts may be very high, between 25 to 50 or more, for very popular subjects. For less popular subjects, the number of facts can be very low, like 5 or 10. # Requirements - If you don't know the subject at all, return an empty list. - If the subject is not a named entity, return an empty list. - Include at least one triple where predicate is "instanceOf". - Do not get too wordy. - Separate several objects into multiple triples with one object.
Input
Subject: PRAC Description of subject: PRAC is a committee within the European Medicines Agency responsible for assessing and monitoring the safety of human medicines.
Referenced by (2)
Full triples — surface form annotated when it differs from this entity's canonical label.