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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 in adherence to:

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

Collection of
Safety Data
Management
of Safety Data
Safety
Database Entry

Monitoring
of Drug Safety
Profile

Follow-Up of
Safety Data

Internationally agreed standards

 oding of Adverse Events using the current MedDRA terminology


C
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 Holders
pharmacovigilance system, including the Pharmacovigilance System Master File
(PSMF)
acting as a single contact point for the Competent Authorities on a 24-hour basis

fgk-pv.com
FGK PharmacovigilanceGmbH
Heimeranstrasse 35
80339 Munich, Germany
Phone +49 (0) 89 893 119-0
+49 (0) 89 893 119-20
Fax
E-mail info@fgk-pv.com

Why FGK
Pharmacovigilance
GmbH?

 e record and process all received ICSRs and other safety data not qualifying as
W
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.

Please feel free to contact one of


the Managing Directors:

Edgar J. Fenzl | MD PhD


FGK PharmacovigilanceGmbH
Heimeranstrasse 35
80339 Munich, Germany
Phone +49 (0) 89 893 119-22
+49 (0) 172 673 8556
Cell
E-mail edgar.fenzl@fgk-pv.com

Anthony W. Fox | MD PhD FRCP FFPM


c/o EBD Group
2032 Corte del Nogal, Suite 120
Carlsbad, CA 92011, USA
Phone +1 (760) 930-0500
+1 (760) 809-3415
Cell
E-mail anthony.fox@fgk-pv.com