Clinical Trials Facilitation and Coordination Group

E553856

The Clinical Trials Facilitation and Coordination Group is a working group under the Heads of Medicines Agencies that focuses on harmonizing and streamlining clinical trial assessment and regulation across European countries.

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Statements (38)

Predicate Object
instanceOf regulatory coordination body ⓘ
working group ⓘ
abbreviation CTFG ⓘ
activity development of common positions on clinical trial regulatory issues ⓘ
drafting of guidance documents on clinical trials for regulators and stakeholders ⓘ
exchange of experience between national authorities on clinical trial assessment ⓘ
support to harmonized implementation of EU Clinical Trials Directive and Regulation ⓘ
collaboratesWith European Medicines Agency ⓘ
national competent authorities for medicines in EU and EEA Member States ⓘ
country European countries ⓘ
field clinical trials regulation ⓘ
medicines regulation ⓘ
focus clinical trial authorization procedures ⓘ
good clinical practice implementation ⓘ
implementation of EU clinical trials legislation ⓘ
regulatory guidance for sponsors and investigators ⓘ
goal enhance patient safety in clinical research through coordinated regulation ⓘ
improve efficiency of clinical trial assessment in Europe ⓘ
reduce regulatory divergence between European countries for clinical trials ⓘ
hasMember representatives of national medicines agencies in EU and EEA ⓘ
jurisdiction European Economic Area Member States ⓘ
European Union Member States ⓘ
language English ⓘ
parentOrganization Heads of Medicines Agencies Clinical Trials Working Group structure ⓘ
partOf Heads of Medicines Agencies ⓘ
purpose coordination between national competent authorities on clinical trials ⓘ
facilitation of multinational clinical trials in Europe ⓘ
harmonization of clinical trial assessment in Europe ⓘ
streamlining clinical trial regulation across European countries ⓘ
regionServed Europe ⓘ
sector pharmaceutical regulation ⓘ
public health ⓘ
supervises harmonized approaches to clinical trial assessment among member authorities ⓘ
topic assessment of clinical trial safety and efficacy data ⓘ
ethics and regulatory interface in clinical trials ⓘ
multinational clinical trial applications ⓘ
risk-based approaches to clinical trial oversight ⓘ
website https://www.hma.eu/ctfg.html ⓘ

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Full triples — surface form annotated when it differs from this entity's canonical label.

HMA → hasWorkingGroup → Clinical Trials Facilitation and Coordination Group ⓘ