FGK Representative Service

FGK Representative Service meets legal requirements of sponsor companies that do not have a subsidiary within the European Union, Switzerland and the United Kingdom, for the purpose of performing clinical research projects in this region.

Regulations (EU) 536/2014 for Clinical Drug Trials (CTR), Regulation (EU) 2017/745 for Medical Devices (MDR) and Regulation (EU) 2017/746, the In-Vitro-Diagnostic Medical Device Regulation (IVDR) require that a sponsor who is not based in the EU must appoint a representative if this sponsor wishes to conduct a clinical study in the EU.

Similarly, the Swiss Ordinances on Clinical Drug Trials and Clinical Investigations with Medical Devices also ask for a Swiss Representative if the sponsor is not established in Switzerland.

Since the Brexit, a local representative in the United Kingdom is also mandatory for conducting clinical studies, however, for the time being a representative in the EU is still accepted.

FGK Pharmacovigilance GmbH

FGK Pharmacovigilance GmbH is a growing offspring of FGK Clinical Research GmbH, a full service Clinical Research Organisation headquartered in Munich, Germany. Besides being young, thriving and enticing to work for, FGK-PV is run by seasoned experts, who are bringing with them knowledge of authorities on both sides of the Atlantic, time-proven safety experience and a steady hand.

FGK PV offers:

  • Management of Adverse Events and Signals from a variety of sources
  • Preparation of periodic safety update reports
  • Preparation of ad hoc safety reports, opinions, or statements specifically tailored to requests of competent authorities
  • Safety profile characterization of medicinal product
  • Planning of pharmacovigilance activities to increase knowledge about the safety profile of the medicinal product

Management of risk minimization activities, including assessment of effectiveness of these activities