Statements (110)
| Predicate | Object |
|---|---|
| gptkbp:instance_of |
gptkb:government_agency
gptkb:regulations |
| gptkbp:advises |
Member states
|
| gptkbp:affiliation |
gptkb:European_Commission
|
| gptkbp:case_outcome |
Marketing Authorization Applications
|
| gptkbp:collaborates_with |
Global health initiatives
National Competent Authorities |
| gptkbp:collaboration |
Stakeholders
|
| gptkbp:communication |
Industry stakeholders
|
| gptkbp:conducts_surveys_on |
Patient safety
|
| gptkbp:coordinates |
Pharmacovigilance activities
|
| gptkbp:coordinates_with |
gptkb:European_Centre_for_Disease_Prevention_and_Control
|
| gptkbp:develops_policies_for |
Regulatory frameworks
|
| gptkbp:engages_in |
Public consultations
|
| gptkbp:established |
gptkb:1995
|
| gptkbp:evaluates |
Clinical trial applications
|
| gptkbp:facilitates |
Access to medicines
|
| gptkbp:function |
gptkb:information_dissemination
gptkb:regulations data analysis regulatory compliance risk management data sharing stakeholder engagement training and education collaboration with industry public health protection evaluation of medicinal products advisory role scientific advice post-marketing surveillance regulatory science collaboration with international organizations collaboration with academic institutions support for innovation support for public health initiatives guidance on clinical trials collaboration with healthcare professionals guidance on market access support for health technology assessment scientific evaluation promotion of research authorization of medicines collaboration with health authorities guidance on pharmacovigilance monitoring of safety of medicines guidance on drug development support for orphan drugs collaboration with EMA committees collaboration with WHO collaboration with national agencies collaboration with patient organizations collaboration with regulatory authorities collaboration with research networks coordination of clinical trials guidance on clinical trial applications guidance on quality standards guidance on regulatory submissions monitoring of clinical trials scientific advice meetings support for advanced therapies support for biosimilars support for generic medicines support for personalized medicine support for vaccine development Scientific evaluation of medicines |
| gptkbp:governing_body |
gptkb:European_Union
|
| gptkbp:headquarters |
gptkb:Amsterdam,_Netherlands
gptkb:Amsterdam |
| https://www.w3.org/2000/01/rdf-schema#label |
European Medicines Agency
|
| gptkbp:innovation |
Biotechnology products
|
| gptkbp:is_a_resource_for |
Healthcare professionals
|
| gptkbp:issues |
Public health emergencies
|
| gptkbp:issues_reports_on |
Drug evaluation outcomes
|
| gptkbp:key_people |
gptkb:Emer_Cooke
|
| gptkbp:location |
gptkb:Amsterdam
|
| gptkbp:manages |
European Union drug approval process
|
| gptkbp:manages_database |
gptkb:European_Union_Clinical_Trials_Register
|
| gptkbp:mission |
Evaluate medicines for human and veterinary use
|
| gptkbp:notifications |
Drug recalls
|
| gptkbp:offers_courses_in |
Regulatory science
|
| gptkbp:offers_workshops_on |
Regulatory science training
|
| gptkbp:oversees |
Pharmaceutical market authorization
|
| gptkbp:parent_organization |
gptkb:European_Commission
gptkb:European_Union |
| gptkbp:participates_in |
International conferences
|
| gptkbp:promotes |
gptkb:Public_health
|
| gptkbp:provides_access_to |
Medicinal products in the EU
|
| gptkbp:provides_guidance_on |
Clinical trials
Public health policies Pharmacovigilance Good Manufacturing Practice Drug development process Risk management plans |
| gptkbp:provides_information_on |
Medicinal products
|
| gptkbp:provides_support_for |
Innovative medicines
Health technology assessment Clinical research initiatives |
| gptkbp:region |
gptkb:European_Economic_Area
|
| gptkbp:regulates |
Pharmaceuticals
|
| gptkbp:reports_to |
gptkb:Annual_reports
|
| gptkbp:reviews |
Drug safety data
|
| gptkbp:supports |
Orphan drug designation
|
| gptkbp:type |
gptkb:regulations
decentralized agency |
| gptkbp:updates |
Regulatory changes
|
| gptkbp:website |
www.ema.europa.eu
|
| gptkbp:works_with |
European Medicines Regulatory Network
|
| gptkbp:bfsParent |
gptkb:Food_and_Drug_Administration
|
| gptkbp:bfsLayer |
3
|