Pharmacovigilance

Our Pharmacovigilance professionals offer PVG support, which can include global and/or local PV services.

  • PV for Marketed Products

    Our Pharmacovigilance professionals offer:

    • Expert advice on PV system requirements
    • Providing Qualified PV personnel (a QPPV, QPPV deputy, local PV contact and medically qualified personnel)
    • Development, implementation and maintenance of the PV system
    • Preparation and maintenance of PSMF
    • Preparation and maintenance of Pharmacovigilance SOPs and other controlled quality documents
    • Preparation or review of PV agreements or safety data exchange agreements with business partners
    • A safety data receipt and processing
    • Signal detection and evaluation
    • Regular worldwide and local literature screening for case reports and other safety information
    • Electronic- or paper-based reporting to EMA and European competent authorities
    • Preparation of Periodic Safety Update Reports, Summary Bridging Reports, Addendum Reports, and other Aggregate Safety Reports
    • Risk Management Plans
    • PV trainings for PV and non-PV personnel
    • Creation of XEVPRMs
    • PV Audits, preparation of Corrective Action Plan, implementation of CAPA
    • Labelling evaluation and variations
    • Crisis management

     

    We can also offer our support in PV for veterinary products.

  • PV for Clinical Trials

    Clinres Farmacija has the experienced professionals you need to develop an effective pharmacovigilance program. Clinres Farmacija uses several providers of PVG Systems (ARISg).

    Clinres Farmacija offers complete drug safety development services, including:

    Safety Surveillance Services

    • o Non-Serious and Serious Adverse Event Case Processing
      • Data Entry, MedDRA and WHO-DD Coding
      • SAE Narrative Writing
      • Physician Medical Review
      • Generation of MedWatch 3500A/CIOMS I Forms
    • Preparation of Reports
      • Periodic Safety Update Reports (PSURs)
      • Periodic Adverse Drug Experience Reports (PADERs)
      • EU Annual Safety Report (EASR)
      • Pre- and Post-Clinical Risk Management Plans (EU RMPs)
    • Risk Minimization Action Plan (RiskMAP)
    • Risk Evaluation and Mitigation Strategy (REMS)
    • Risk Management Plans
    • Scientific Literature Review
    • Safety Data Reconciliation
    • Establishment of Database Systems and Standard Operating Procedures (SOPs)
    • Safety Systems and Processes assessment

    We offer dedicated phone and fax lines which enable you to personally contact a safety officer.

“Research is creating new knowledge. ”
Neil Armstrong