Affiliates

FGK Representative Service acts as a legal representative for pharmaceutical and biotechnology companies which have no subsidiary within the EU and which submit regulatory applications to the European authorities.

The Clinical Trials Directive (2001/20/EC), implemented May 1, 2004, requires that a legal representative of the sponsor be established in the EU for all clinical trials conducted in the EU. This is why it is no longer possible for a company outside the EU to conduct a clinical study without an entity representing them in the EU.

Directive 2001/83/EC requires that for a marketing authorization application in the EU the applicant has to be established in the EU.

Regulation (EC) No 141/2000 requires that the sponsor seeking to obtain or having obtained the designation of a medicinal product as an orphan medicinal product from the EMEA must be established in the EU.

As of 26 May 2021 the new Regulation (EU) 2017/745, the Medical Device Regulation (MDR) will come into application for new clinical investigations with medical devices. EU member states will need to decide whether pursuant to Article 62. 2 (1) of MDR a legal representative of non-EU sponsors should be appointed or pursuant to Art 62. 2 (2) MDR a contact person in the EU will be sufficient. FGK Representative Service will provide both services for sponsors not established in the EU.

www.fgk-rs.com

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

www.fgk-pv.com