PHARMACOVIGILANCE

Human medicines

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Human medicines

The development of the new pharmacovigilance legislation, which was the biggest change to the regulation of human medicines in the European Union (EU) since 1995, was based on the observation that adverse drug reactions (ADRs), ‘noxious and unintended’ responses to a medicine, caused around 197,000 deaths per year in the EU.

WE OFFER YOU

  • Compliance with guidelines on Good Pharmacovigilance Practices (GVP)
  • Services of a QPPV (24/7) with access to medical adviser
  • Establishment and maintenance of the Pharmacovigilance system and Pharmaocivigilance system master file (PSMF), including Quality System
  • Management of Critical pharmacovigilance processes and business continuity
  • Management and reporting of adverse reactions to medicinal products
  • Weekly monitoring of scientific literature
  • Ongoing benefit-risk evaluation
  • Preparation of Risk Management Plan and Risk minimisation measures
  • Medical writing (PSUR, RMP, etc.)
  • Signal detection and evaluation
  • Managing PASS, PAES
  • Regulatory actions (safety variations, communications with stakeholders, etc.)
  • Electronic transmission of the pharmacovigilance data (Article 57), selection of appropriate tool and implementation of quality system
  • Trainings of personnel
  • Setting up appropriate Contractual arrangements and supervision
  • Audit and Pre-inspection consultations
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