Vigilance Reporting
Found 3 free book(s)Guideline on good pharmacovigilance practices (GVP)
www.ema.europa.euThis Module contains guidance on the planning, conduct, reporting and follow -up of pharmacovigilance inspections in the EU and outlines the role of the different parties in volved. General guidance is provided under III.B., while III.C. covers the overall operation of pharmacovigilance inspections in the EU.
MedTech Europe guidance for assigning Basic UDI-DI
www.medtecheurope.org• Vigilance and Post-Market Surveillance Reports (auto-populated in EUDAMED if form is completed online): o Manufacturer Incident Reporting form (MIR) o Periodic Summary Update Report (PSUR) o Field Safety Corrective Action Reporting form (FSCAR form) o Periodic Summary Report form (PSR) ...
Guideline on good pharmacovigilance practices (GVP)
www.ema.europa.euEU competent authority for the protocol oversight and reporting of results ( VIII.C.2.) and for subsequent changes to the marketing authorisation ( VIII.C.3.). Legal requirements are identifiable by the modal verb “shall”. Recommendations that are not legal requirements are.