European Medicines Agency's Committee for Human Medicinal Products
GPTKB entity
Statements (63)
| Predicate | Object |
|---|---|
| gptkbp:instanceOf |
gptkb:Committee
|
| gptkbp:advises |
post-marketing studies
|
| gptkbp:analyzes |
new regulations
|
| gptkbp:collaboratesWith |
academic institutions
other regulatory authorities |
| gptkbp:communityFeedback |
clinical trial applications
|
| gptkbp:composedOf |
experts in various fields
|
| gptkbp:contributedTo |
regulatory science
safety monitoring of medicines healthcare_policy_development |
| gptkbp:engagesIn |
public consultations
|
| gptkbp:ensures |
transparency in decision-making
|
| gptkbp:evaluates |
therapeutic indications
market access strategies clinical efficacy therapeutic equivalence benefit-risk balance of medicines pharmaceutical quality |
| gptkbp:facilitates |
stakeholder engagement
scientific discussions |
| https://www.w3.org/2000/01/rdf-schema#label |
European Medicines Agency's Committee for Human Medicinal Products
|
| gptkbp:isRecognizedFor |
clinical trials
clinical practice risk management plans labeling of medicines post-marketing surveillance. |
| gptkbp:issueFeePaid |
safety concerns
clinical trial design generic medicines data protection in clinical trials medicine safety |
| gptkbp:issues |
opinions on marketing authorizations
|
| gptkbp:meets |
regularly to discuss applications
|
| gptkbp:monitors |
emerging health threats
|
| gptkbp:participatesIn |
international collaborations
scientific meetings scientific committees |
| gptkbp:partOf |
gptkb:European_Medicines_Agency
|
| gptkbp:promotes |
innovation in medicine development
|
| gptkbp:provides |
scientific advice
|
| gptkbp:providesGuidanceOn |
risk assessment
clinical development programs |
| gptkbp:providesInformationOn |
gptkb:European_Commission
scientific research initiatives health technology assessments |
| gptkbp:providesSupportFor |
regulatory submissions
|
| gptkbp:providesTrainingFor |
regulatory processes
|
| gptkbp:publishes |
guidelines for industry
|
| gptkbp:responsibleFor |
evaluation of human medicines
|
| gptkbp:reviews |
clinical guidelines
manufacturing processes safety protocols clinical trial data safety data pharmacovigilance data orphan_medicines |
| gptkbp:secondaryMission |
advanced therapy medicinal products
|
| gptkbp:supports |
public health initiatives
public health research patient safety initiatives medicinal products healthcare_professionals |
| gptkbp:worksWith |
stakeholders in healthcare
|