New EU PV regulations | PPT
EU launches black triangle drug monitoring scheme - PMLiVE
Overview of the European Medicines Agency (EMA), Part 1 of 3 - YouTube
EMA & FDA: What Are the Similarities & Differences in Risk Management Procedures? - Biomapas
Lista de medicamentos sujetos a seguimiento adicional | Pharmya
Frontiers | The Added Value of Patient Engagement in Early Dialogue at EMA: Scientific Advice as a Case Study
conceptually similar components between Food and drug admin-... | Download Scientific Diagram
APsystems upgrades EMA monitoring website with more data and improved interface - APsystems EMEA
GVP Module Additional Monitoring
4. EudraVigilance
Monitoring evidence on overall survival benefits of anticancer drugs approved by the European Medicines Agency between 2009 and 2015 - ScienceDirect
Should Medicines With a PASS be Excluded From Additional Monitoring? EC Says Not Yet | RAPS
EU Commission Report on National and EMA experience on Medicines subject to Additional Monitoring released today
Medicinal products under additional monitoring – NAMMDR
EMA
Improving the Safety of Medicines in the European Union: From Signals to Action - Potts - 2020 - Clinical Pharmacology & Therapeutics - Wiley Online Library
Promoting and Protecting Public Health: How the European Union Pharmacovigilance System Works. - Abstract - Europe PMC
PDF) Does additional monitoring status increase the reporting of adverse drug reaction s ? An interrupted time series analysis of EudraVigilance data
EMA Pharmacovigilance Regulations Updates
EMA updates SmPC and package leaflet templates with new black symbol | Signs & Symptoms of Translation
Centralized procedure of Marketing Authorization: Procedural Advice
Additional-monitoring factsheet (EN)
Established products to exit EU list of Black Triangle Products ? - Safety Observer
