pharmacovigilance

The European pharmacovigilance system intends to provide patients and consumers with the best possible safety in using medicinal products.
Based on the recommendations provided in the guideline on Good Pharmacovigilance Practices (GVP), we offer to support you in all pharmacovigilance issues:

case report management/individual case safety reports (ICSRs)

We support you in processing your case reports and adverse reaction notifications or take over your complete case report management, the assessment of adverse drug reactions and the notification of the authorities.

  • collection and management of all adverse reaction reports: spontaneous reports, notifications from authorities (e. g. BfArM), suspected cases from literature and from clinical studies
  • literature search for case reports in medical databases and publication platforms
  • collection, processing and assessment of all incoming reports (including follow-up)
  • transmission of reportable case reports to the competent national and international authorities in due time
  • maintenance of your pharmacovigilance database
periodic reports (PSURs, DSURs)

We offer the compilation of Periodic Safety Update Reports (PSURs) in the GVP format.

  • incorporation of specific information on the medicinal product, such as status of marketing authorisation, product information or calculation of patient exposure.
  • evaluation of adverse reaction notifications and adverse events in clinical trials
  • literature search on the efficacy and safety of the medicinal product and/or the drug substance contained
  • detailed analysis of information with respect to possible risks to the patient
  • assessment of the risk-benefit ratio of the medicinal product and comparison to the risk management plan and, as appropriate, its updating
  • PSUR submission to the competent authorities
risk management system (RMS)

The risk management plan (RMP) is the product-related detailed description of the risk management system of a marketing authorisation holder. All activities and measures taken to identify, characterise, reduce or prevent potential risks posed by the medicinal product are checked for efficiency.

We offer the

  • GVP compliant compilation of risk management plans (RMPs)
  • continuous monitoring of the risk posed by a medicinal product (ICSRs, literature search, signal detection)
  • identification, assessment and quantification of the safety profile of a medicinal product
  • compilation of action plans to minimise potential risks
  • support in implementing measures and their subsequent assessment
  • management of the PSUR-relevant RMP modules
Extended EudraVigilance Product Report Message / Medicinal Product Dictionary (XEVPRM/XEVMPD)

Pursuant to Article 57 of EC Regulation No. 726/2004 it is necessary to send comprehensive information to your authorised medicinal products to the European Medicines Agency (EMA) and to continuously update it. We offer our support in the

  • search for efficient solutions to reduce the processing effort
  • technical conception (solution via database system or entry via EVWEB)
  • data entry, transmission to EMA and document management (XML file, confirmation of transmission and receipt, etc.)
  • registration with EudraVigilance
further pharmacovigilance services
  • consultancy and support in the establishment, optimisation and revision of your pharmacovigilance system
  • compilation and management of Pharmacovigilance System Master Files (PSMF)
  • compilation, review and management of SOPs
  • training of employees and sales force
  • performance of system audits (self-inspections)
  • adoption of the duties of responsible persons (EU-QPPV, Graduated Plan Officer and Information Officer)
  • responsibility for pharmacovigilance in clinical trials


We have an complete pharmacovigilance system in place with a European Qualified Person for Pharmacovigilance (EU-QPPV)/Graduated Plan Officer, EudraVigilance (EV) registration and a Pharmacovigilance System Master File (PSMF). Therefore we can manage your products over their entire life cycle and apply for registration / marketing authorisation on your behalf.

Contact: Karlheinz Gutzler, Deputy Head of Vigilance & Quality Services
Email: k.gutzler(at)hwi-group.de
Phone: +49 7272 7767-2525

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