EU Qualified Person for Pharmacovigilance (QPPV)
January 1, 2000/by Dave JacobsPV System Master File (PSMF)
January 1, 2000/by Dave JacobsICSRs/SUSAR processing
January 1, 2000/by Dave JacobsLocal (QP)PV support and AEs/MI/PQC processing
January 1, 2000/by Dave JacobsExpedited reporting
January 1, 2000/by Dave JacobsXEVMPD population and maintenance
January 1, 2000/by Dave JacobsPeriodic reporting (PSURs/PBRERs/ Addenda to the CO/DSURs)
January 1, 2000/by Dave JacobsGlobal and local literature screening and review
January 1, 2000/by Dave JacobsRisk Management Plans (RMPs)
January 1, 2000/by Dave JacobsSignal detection and evaluation – benefit/risk assessment in safety review meetings
January 1, 2000/by Dave JacobsSafety Data Exchange Agreements
January 1, 2000/by Dave JacobsCommunication with National Competent Authorities
January 1, 2000/by Dave JacobsTraining in pharmacovigilance
January 1, 2000/by Dave JacobsAudits preparation
January 1, 2000/by Dave JacobsOrganisation set-up and changes
January 1, 2000/by Dave JacobsPV SOPs and other controlled operating instructions
January 1, 2000/by Dave JacobsPost-Authorisation Safety Study
January 1, 2000/by Dave JacobsDADA CONSULTANCY
DADA Consultancy is a highly specialised and independent consultancy agency in international regulatory affairs of human and veterinary medicinal products.
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