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.
Statements (38)
| Predicate | Object |
|---|---|
| instanceOf |
regulatory coordination body
ⓘ
working group ⓘ |
| abbreviation | CTFG NERFINISHED ⓘ |
| 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
NERFINISHED
ⓘ
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
NERFINISHED
ⓘ
European Union Member States NERFINISHED ⓘ |
| language | English ⓘ |
| parentOrganization | Heads of Medicines Agencies Clinical Trials Working Group structure ⓘ |
| partOf | Heads of Medicines Agencies NERFINISHED ⓘ |
| 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 ⓘ |
Referenced by (1)
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