Pharmacovigilance services

  • systematic review of bibliographic information (weekly review of the literature) for the accomplishment of a group of medicinal products and active substances in particular on individual cases of adverse events (case reports), comparative clinical studies, overdose cases, increasing the incidence of the adverse reaction, detection of signals,
  • reports of serious or unexpected, undescribed adverse reactions of medicinal products manufactured by your company, the assessment and classification of recorded adverse action, and evaluation of cause – effect,
  • preparing Periodic Safety Update Reports in Polish and English for the Drug Control Agencies relating to the safety of medicinal products (PSUR),
  • providing quick and complete answers, at the request of the Drug Control Agencies to provide any additional information necessary to evaluate the benefits and risks associated with the use of the medical product group,
  • electronic reporting to the European Medicines Agency (EMEA) or other agencies through an application for registration EVWEB or gate company,
  • preparation of Detailed Description of Pharmacovigilance System tailored to company’s needs, based on our PV system (Module 1.8.1 of registration dossier),
  • preparation of Risk-management plans for specific products (Module 1.8.2 of registration dossier),
  • preparation of Standard Operating Procedures for PV system.

Adverse reaction form