Medicinal Products

EU QPPV
Local QP/contact persons for PV in the EU member states
Clinical Trials and post-marketing Vigilance
Annual safety reports (ASRs) (for NCA and ECs)
Case processing for ISCRs/SAEs (Including collection, collation, coding analysis, reporting and electronic archiving of the ADRs)
Consultancy strategy and advice
Periodic safety update reports (PSURs)
Risk Management Plans
Safety Data Exchange Arrangements (SDEAs)
Preparation for PV inspections, post-inspection support
Company Core Data Sheets (CCDS) and Core Safety Information (CCSI)
Weekly and bespoke literature searching
Review of safety systems, Standard Operation Procedures (SOP) preparation