Pharmacovigilance Services

Creative PHS is committed to patient safety offering premium and cost-effective solutions for global pre- and post-approval pharmacovigilance as well as related services in product safety.
 
  • Post-marketing pharmacovigilance
    • Establishment and maintenance of Pharmacovigilance System, including writing of related SOPs and Pharmacovigilance System Master File (PSMF)
    • Provision of EU QPPV/Deputy EU QPPV or Local QPPV/Representatives to Greece & Cyprus
    • 24 hours availability of EU/QPPV and Deputy EU/QPPV
    • ΜΑΗ registration to SME & Eudravigilance database
    • Scientific Global & Local Literature Surveillance
    • Management of AEs/ADRs and other relevant safety information from any source
    • Electronic submission of information on MAH medicinal products to XEVMPD
    • Preparation and submission of Aggregate Safety Reports
    • Preparation and submission of Risk Management Systems
    • DHPC Management
    • Storage and protection of Pharmacovigilance records
    • Monitoring of Product Safety/Signal Detection
    • Preparation for Pharmacovigilance Audits/Inspections
    • Safety Data Exchange Agreements (SDEA) preparation/review and maintenance
    • Pharmacovigilance Training
  • Clinical/Pre-approval pharmacovigilance
    • Provision of Responsible Person for pharmacovigilance (RP) for clinical trials
    • Eudravigilance registration
    • Assessment and medical review of serious adverse events
    • SUSAR reporting to Eudravigilance and Competent Authorities/Site Investigators
    • Ongoing risk/benefit assessment of the IMP
    • Compilation and update of the Clinical Safety Reports (DSUR)
    • Contribution to the Clinical Study Report

Creative Pharma Services is an ISO certified company

HQ: 286 Kifisias Ave., Halandri 152 32, Athens, Greece
Tel:  +30 210 32 59 350
Fax: +30 210 32 59 380
info@creativephs.com