Set up of FGK Pharmacovigilance GmbH

Press Release

FGK Pharmacovigilance GmbH is a pharmacovigilance service provider offering the
full range of services as related to the continuous monitoring of the risk-benefit balance
of authorised medicinal products and operation of their risk management system. This
includes the systematic collection, processing, analysis and reporting of safety data from
a variety of sources.

Regulatory Guidelines

  • Reporting of Individual Case Safety Reports (ICSRs)
  • Reporting of emerging safety issues
  • Preparation, review, and submission of periodic safety update reports (PSURs), including new-format risk-benefit assessment sections
  • Handling of responses to requests from Competent Authorities and preparation of ad hoc safety reports
  • Preparation of stand-alone risk management plans
  • Conduct of periodic global literature searches

Internationally agreed standards

  • Coding of Adverse Events using the current MedDRA terminology
  • Standardization of reported medications according to WHO Drug Dictionary

As an integral part of our pharmacovigilance services we are providing the services of the EU Qualified Person for Pharmacovigilance (QPPV) and, thus, are capable of:

  • establishing and maintaining/managing the Marketing Authorisation Holder’s pharmacovigilance system, including the Pharmacovigilance System Master File (PSMF)
  • acting as a single contact point for the Competent Authorities on a 24-hour basis

Why FGK Pharmacovigilance GmbH?

  • We record and process all received ICSRs and other safety data not qualifying as ICSR, but relevant for the product risk-benefit balance analysis
  • We take care of pharmacovigilance signal management, including signal detection, validation, analysis and assessment, with risk minimization planning therefrom
  • We use advanced validated safety database solutions and have all capabilities necessary to transmit safety reports to the EudraVigilance database
  • We periodically evaluate the effectiveness of the risk minimization activities described in the product risk management plan
  • We continuously monitor and assess the risk-benefit profile of your medicinal products
  • We design your pharmacovigilance system and set up and maintain the Pharmacovigilance System Master File
  • We ensure that QPPV services are performed by highly experienced and appropriately qualified medical professionals
  • We perform self-evaluations against performance benchmarks and conduct pharmacovigilance audits and training of service providers, licensing partners and contractors on a regular basis
  • We offer customized solutions where the services provided to you may be set-up in a modular way

The legal framework of our pharmacovigilance services for medicines marketed within the EU is provided in Regulation (EC) No 726/2004 as amended by Regulation (EU) No 1235/2010, in Directive 2001/83/EC as amended by Directive 2010/84/EU and in Implementing Regulation (EU) 520/2012. Furthermore, the guidance on good pharmacovigilance practices (GVP) as well as pertinent ICH and CIOMS guidelines build up the framework for the conduct of our pharmacovigilance business.