# FGK Group

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## Pages
- [Confirmation Consultation](https://fgk-group.com/fgk-rs/representative-service-consultation/confirmation/)
- [Representative Service Consultation](https://fgk-group.com/fgk-rs/representative-service-consultation/)
- [Start DE](https://fgk-group.com/)
- [Start](https://fgk-group.com/)
- [FGK CRO](https://fgk-group.com/fgk-cro/)

## News \& Events \- News
- [Scale Up Europe Fund](https://fgk-group.com/news-events/news/scale-up-europe-fund/): A €5bn Scaleup Europe Fund has been launched to support strategic technology businesses which may benefit European biotech companies\.
- [Scale\-Up\-Europe\-Fonds](https://fgk-group.com/news-events/news/scale-up-europe-fund/): Am 3\. Juni wurde der mit 5 Mrd\. Euro dotierte „Scale\-Up\-Europe\-Fonds“ auf dem Gipfeltreffen des Europäischen Innovationsrats \(EIC\) in Brüssel offiziell ins Leben gerufen\.
- [FGK Clinical Research establishes operational presence in the Netherlands to bolster European clinical trial landscape](https://fgk-group.com/news-events/news/fgk-clinical-research-establishes-operational-presence-in-the-netherlands/): Press Release
- [FGK Clinical Research establishes operational presence in the Netherlands to bolster European clinical trial landscape](https://fgk-group.com/news-events/news/fgk-clinical-research-establishes-operational-presence-in-the-netherlands/): Press Release
- [Insights from the EMA GCP Inspectors’ Working Group Annual Report](https://fgk-group.com/news-events/news/insights-from-the-ema-gcp-inspectors-working-group-annual-report/): If you think your study has a lot going on, wait until you see what 2024 looked like on the inspection side\!…

## News \& Events \- Events
- [BIO\-Europe](https://fgk-group.com/news-events/events/bio-europe/): FGK participates with Ursula Türcke, Martin Krauss, Jennifer de la Peña and Olaf Böhm at BIO\-Europe in Cologne, Germany\.
- [BIO\-Europe](https://fgk-group.com/news-events/events/bio-europe/): FGK participates with Ursula Türcke, Martin Krauss, Jennifer de la Peña and Olaf Böhm at BIO\-Europe in Cologne, Germany\.
- [BIOSPAIN](https://fgk-group.com/news-events/events/biospain/): FGK participates with Ursula Türcke, Jennifer de la Peña and Martin Krauss at BIOSPAIN in Bilbao, Spain\. 
- [World Drug Safety](https://fgk-group.com/news-events/events/world-drug-safety/): FGK participates with Jennifer de la Peña, Angela Denzel and Zurab Koberidze at World Drug Safety in Amsterdam, the Netherlands\.
- [BIOSPAIN](https://fgk-group.com/news-events/events/biospain/): FGK participates with Ursula Türcke, Jennifer de la Peña and Martin Krauss at BIOSPAIN in Bilbao, Spain\. 

## Knowledge Hub \- Magazine
- [The €5 Billion Scaleup Europe Fund](https://fgk-group.com/knowledge-hub/magazine/the-e5-billion-scaleup-europe-fund/): This article explains how the “Scaleup Europe Fund” aims to strengthen late\-stage financing for Europe’s most innovative companies and, in doing so, could reshape the financing landscape in the European life sciences sector\.
- [GCP\-Schnipsel: Protokoll\-Checklisten im Wettbewerb](https://fgk-group.com/knowledge-hub/magazine/gcp-snippets-protocol-checklists-in-competition/): Auch wenn ICH E6 \(R3\) keine vollständig umfassende Checkliste aller möglichen und notwendigen Protokollelemente enthält, bietet es doch die am häufigsten verwendete Beschreibung des allgemeinen Protokollinhalts\.
- [GCP\-Schnipsel: Mit dem Ungewissen umgehen](https://fgk-group.com/knowledge-hub/magazine/gcp-snippets-compliance-with-the-unknown/): In der Regel bestätigen Sponsoren und Prüfer die Einhaltung der Vorschriften, indem sie auf der gepunkteten Linie unter genau dieser Erklärung unterschreiben\. Aber halten sie sich tatsächlich an die ICH\-GCP\-Richtlinien, sind sie dazu in der Lage, und wissen sie überhaupt, wie sie diese einhalten sollen?
- [GCP Snippets: Compliance with the unknown](https://fgk-group.com/knowledge-hub/magazine/gcp-snippets-compliance-with-the-unknown/): Usually sponsors and investigators confirm compliance by signing on a dotted line beneath this very statement\. But do they actually comply with ICH GCP, are they enabled to comply, and could they know how to comply?
- [GCP\-Schnipsel: Die überarbeiteten ICH\-GCP\-Leitlinien treten in ihr viertes Jahrzehnt ein](https://fgk-group.com/knowledge-hub/magazine/gcp-snippets-a-revamped-ich-gcp-enters-its-fourth-decade/): Wir nehmen Sie mit auf ene Reise durch die Tiefen des GCP\-Dschungels\.

## Knowledge Hub \- Glossary
- [Phase Clinical Trial](https://fgk-group.com/knowledge-hub/glossary/phase-clinical-trial/): A phase of a clinical trial refers to the stage of development that a potential new drug therapy is in\. A clinical trial can be a Phase I, Phase II, Phase III or Phase IV\.
- [Prüfer / Prüfarzt](https://fgk-group.com/knowledge-hub/glossary/investigator/): Die Person, die für die Durchführung einer klinischen Studie an einem Studienort verantwortlich ist und häufig ein Forschungsteam leitet\.
- [UK Clinical Trial Regulations](https://fgk-group.com/knowledge-hub/glossary/uk-clinical-trial-regulations/): UK clinical trial regulations are the regulatory framework that apply specifically to clinical trials of investigational medicinal products \(CTIMPs\) conducted in the UK\.
- [European Clinical Research Organization](https://fgk-group.com/knowledge-hub/glossary/european-clinical-research-organization/): Contract Research Organization located in Europe that conducts clinical studies for sponsor companies\.
- [Pivotal Clinical Trial](https://fgk-group.com/knowledge-hub/glossary/pivotal-clinical-trial/): Clinical trials that are conducted in the intended target population with the intend to gather safety and efficacy data for regulatory approval\.

## Career
- [Unsolicited application](https://fgk-group.com/career/unsolicited-application-initiativbewerbung/)
- [Initiativbewerbung](https://fgk-group.com/career/unsolicited-application-initiativbewerbung/)
- [Clinical Research Associate \(CRA\) / Monitor \(f/m/d\)](https://fgk-group.com/?post_type=career&p=9794)
- [Why us](https://fgk-group.com/career/why-us/)
- [Warum wir](https://fgk-group.com/career/why-us/)

## About Us \- FGK RS
- [FGK Representative Service Ltd](https://fgk-group.com/fgk-rs/about-us/fgk-rs-ltd/)
- [FGK Representative Service Ireland Ltd](https://fgk-group.com/fgk-rs/about-us/fgk-representative-service-ireland-ltd/)
- [FGK Representative Service BV](https://fgk-group.com/fgk-rs/about-us/fgk-rs-bv/)
- [FGK Representative Service Ireland Ltd\.](https://fgk-group.com/fgk-rs/about-us/fgk-representative-service-ireland-ltd/)
- [FGK Representative Service Ltd\.](https://fgk-group.com/fgk-rs/about-us/fgk-rs-ltd/)

## About Us \- FGK PV
- [Management / QPPV](https://fgk-group.com/fgk-pv/about-us/management-qppv/)
- [Management / QPPV](https://fgk-group.com/fgk-pv/about-us/management-qppv/)
- [Contact](https://fgk-group.com/fgk-pv/about-us/contact/)
- [Kontakt](https://fgk-group.com/fgk-pv/about-us/contact/)

## About Us \- FGK CRO
- [RHEACELL GmbH \& Co\. KG \- CASE STUDY](https://fgk-group.com/fgk-cro/about-us/references/rheacell-gmbh-co-kg-case-study/)
- [Algiax Pharmaceuticals GmbH \- CASE STUDY](https://fgk-group.com/fgk-cro/about-us/references/algiax-case-study/)
- [RHEACELL GmbH \& Co\. KG \- CASE STUDY](https://fgk-group.com/fgk-cro/about-us/references/rheacell-gmbh-co-kg-case-study/)
- [University Hospital Tübingen](https://fgk-group.com/fgk-cro/about-us/references/university-hospital-tubingen/)
- [Referenzen](https://fgk-group.com/fgk-cro/about-us/references/)

## Services \- FGK RS
- [SME\-Status](https://fgk-group.com/fgk-rs/services/sme-status/)
- [Orphan Medicinal Products \(Drugs\)](https://fgk-group.com/fgk-rs/services/orphan-medicinal-products-drugs/)
- [SME Status](https://fgk-group.com/fgk-rs/services/sme-status/)
- [Arzneimittel für Seltene Erkrankungen](https://fgk-group.com/fgk-rs/services/orphan-medicinal-products-drugs/)
- [Marketing Authorization](https://fgk-group.com/fgk-rs/services/marketing-authorization/)

## Services \- FGK PV
- [Pharmacovigilance Services for Pharma, Biotech \& Med\-Device Companies](https://fgk-group.com/fgk-pv/services/pharmacovigilance-services/)
- [Responsible Person](https://fgk-group.com/fgk-pv/services/responsible-person/)
- [List of services](https://fgk-group.com/fgk-pv/services/list-of-services/)
- [Quality System setup](https://fgk-group.com/fgk-pv/services/quality-system-setup/)
- [Daily operation](https://fgk-group.com/fgk-pv/services/daily-operation/)

## Services \- FGK CRO
- [Pharmacovigilance](https://fgk-group.com/fgk-cro/services/pharmacovigilance/)
- [Project Management / Monitoring](https://fgk-group.com/fgk-cro/services/project-management-monitoring/)
- [eSolutions](https://fgk-group.com/fgk-cro/services/esolutions/)
- [Clinical Trial Biostatistics](https://fgk-group.com/fgk-cro/services/clinical-trial-biostatistics/)
- [Clinical Data Management](https://fgk-group.com/fgk-cro/services/clinical-data-management/)

## Expertise \- FGK PV
- [Medical Devices](https://fgk-group.com/fgk-pv/expertise/medical-devices/)
- [Medizinprodukte](https://fgk-group.com/fgk-pv/expertise/medical-devices/)
- [Arzneimittel](https://fgk-group.com/fgk-pv/expertise/medicinal-products/)
- [Medicinal Products](https://fgk-group.com/fgk-pv/expertise/medicinal-products/)

## Expertise \- FGK CRO
- [Seltene Erkrankungen](https://fgk-group.com/fgk-cro/expertise/rare-diseases/): Durch die Erfahrung mit der Durchführung nationaler und internationaler klinischer Studien zu seltenen Krankheiten weiß FGK, welche Herausforderungen bereits in einer frühen Phase der Konzeption von Studien zu seltenen Krankheiten berücksichtigt werden müssen\.
- [Dermatologie](https://fgk-group.com/fgk-cro/expertise/dermatology/): Klinische Studien in der Dermatologie erfordern breites Fachwissen im Bereich bildgebender Verfahren\. FGK hat eine Vielzahl dermatologischer Studien in allen klinischen Phasen durchgeführt\.
- [Gynäkologie / Urologie](https://fgk-group.com/fgk-cro/expertise/gynecology-urology/): FGK verfügt über Erfahrung in der Durchführung von Studien in frühen und späten klinischen Phasen in den Bereichen Frauengesundheit und Urologie\.
- [Gastroenterologie](https://fgk-group.com/fgk-cro/expertise/gastroenterology/): Aufgrund langjähriger Erfahrung bei der Durchführung klinischer Studien zu verschiedenen gastroenterologischen Indikationen kann FGK einen umfassenden Service von Phase I bis Phase IV anbieten\.
- [Ophthalmologie](https://fgk-group.com/fgk-cro/expertise/ophthalmology/): FGK unterstützt klinische Studien der Phasen I bis III im Bereich der Augenheilkunde, sowohl für Arzneimittel als auch für Medizinprodukte\.

## Optional
- [Sitemap index](https://fgk-group.com/sitemap_index.xml)