IRISH MEDICINES BOARD ADDITIONAL MONITORING: BLACK TRIANGLE INTRODUCED AS PROMPT TO REPORT SUSPECTED ADVERSE REACTIONS
Communication campaign: medicines under additional monitoring
GVP Module Additional Monitoring
Medicinal products under additional monitoring – NAMMDR
EMA Pharmacovigilance Regulations Updates
EMA survey on safety of medicines and reporting of adverse drug reactions – EFNA
Additional monitoring - information materials | European Medicines Agency
EU Commission Report on National and EMA experience on Medicines subject to Additional Monitoring released today
Frontiers | The Added Value of Patient Engagement in Early Dialogue at EMA: Scientific Advice as a Case Study
Centralized procedure of Marketing Authorization: Procedural Advice
EMA updates SmPC and package leaflet templates with new black symbol | Signs & Symptoms of Translation
Established products to exit EU list of Black Triangle Products ? - Safety Observer
EU ramps up collection of public health data to improve drug reviews | Reuters
EMA & FDA: What Are the Similarities & Differences in Risk Management Procedures? - Biomapas
4. EudraVigilance
Lista de medicamentos sujetos a seguimiento adicional | Pharmya
Evaluation of quantitative signal detection in EudraVigilance for orphan drugs: possible risk of false negatives | Semantic Scholar
PDF) Does additional monitoring status increase the reporting of adverse drug reaction s ? An interrupted time series analysis of EudraVigilance data
Pharmacovigilance: Overview | European Medicines Agency
EMA
EU launches black triangle drug monitoring scheme - PMLiVE
Communication campaign: medicines under additional monitoring
Medicines under additional monitoring in the European Union
Medicines under additional monitoring in the European Union
Monitoring evidence on overall survival benefits of anticancer drugs approved by the European Medicines Agency between 2009 and 2015 - ScienceDirect
