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001-es BibID:	BIBFORM036727
Első szerző:	Gluud, Christian
Cím:	Typical investigational medicinal products follow relatively uniform regulations in 10 European Clinical Research Infrastructures Network (ECRIN) countries / Christian Gluud, Christine Kubiak, Kate Whitfield, Jane Byrne, Karl-Heinz Huemer, Steffen Thirstrup, Christian Libersa, Béatrice Barraud, Xina Grählert, Gabriele Dreier, Sebastian Geismann, Wolfgang Kuchinke, Zsuzsa Temesvari, Gyorgy Blasko, Gabriella Kardos, Timothy O'Brien, Margaret Cooney, Siobhan Gaynor, Arrigo Schieppati, Fernando de Andres, Nuria Sanz, German Kreis, Charlotte Asker-Hagelberg, Hanna Johansson, Sue Bourne, Adeeba Asghar, Jean-Marc Husson, Jacques Demotes-Mainard
Dátum:	2012
ISSN:	1745-6215
Megjegyzések:	Background In order to facilitate multinational clinical research, regulatory requirements need to become international and harmonised. The EU introduced the Directive 2001/20/EC in 2004, regulating investigational medicinal products in Europe. Methods We conducted a survey in order to identify the national regulatory requirements for major categories of clinical research in ten European Clinical Research Infrastructures Network (ECRIN) countries-Austria, Denmark, France, Germany, Hungary, Ireland, Italy, Spain, Sweden, and United Kingdom-covering approximately 70% of the EU population. Here we describe the results for regulatory requirements for typical investigational medicinal products, in the ten countries. Results Our results show that the ten countries have fairly harmonised definitions of typical investigational medicinal products. Clinical trials assessing typical investigational medicinal products require authorisation from a national competent authority in each of the countries surveyed. The opinion of the competent authorities is communicated to the trial sponsor within the same timelines, i.e., no more than 60 days, in all ten countries. The authority to which the application has to be sent to in the different countries is not fully harmonised. Conclusion The Directive 2001/20/EC defined the term 'investigational medicinal product' and all regulatory requirements described therein are applicable to investigational medicinal products. Our survey showed, however, that those requirements had been adopted in ten European countries, not for investigational medicinal products overall, but rather a narrower category which we term 'typical' investigational medicinal products. The result is partial EU harmonisation of requirements and a relatively navigable landscape for the sponsor regarding typical investigational medicinal products.
Tárgyszavak:	Orvostudományok Gyógyszerészeti tudományok idegen nyelvű folyóiratközlemény külföldi lapban külföldön készült közlemény
Megjelenés:	Trials (electronic resources). - 13 : 27 (2012), p. 1-8. -
További szerzők:	Kubiak, Christine Whitfield, Kate Byrne, Jane Huemer, Karl-Heinz Thirstrup, Steffen Libersa, Christian Barraud, Béatrice Grählert, Xina Dreier, Gabriele Geismann, Sebastian Kuchinke, Wolfgang Temesvári Zsuzsa Kardos Gabriella O'Brien, Timothy Cooney, Margaret Gaynor, Siobhan Schieppati, Arrigo Andres-Trelles, Fernando de Sanz, Nuria Kreis, German Asker-Hagelberg, Charlotte Johansson, Hanna Bourne, Sue Asghar, Adeeba Husson, Jean-Marc Demotes-Mainard, Jacques Blaskó György (1947-) (belgyógyász, klinikai farmakológus)
Internet cím:	Intézményi repozitóriumban (DEA) tárolt változat DOI
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001-es BibID:	BIBFORM037465
035-os BibID:	PMID:21073691
Első szerző:	Whitfield, Kate
Cím:	Compassionate use of interventions : results of a European Clinical Research Infrastructures Network (ECRIN) survey of ten European countries / Kate Whitfield, Karl-Heinz Huemer, Diana Winter, Steffen Thirstrup, Christian Libersa, Béatrice Barraud, Christine Kubiak, Lea Stankovski, Xina Grählert, Gabriele Dreier, Sebastian Geismann, Wolfgang Kuchinke, Anke Strenge-Hesse, Zsuzsa Temesvari, György Blasko, Gabriella Kardos, Timothy O'Brien, Margaret Cooney, Siobhan Gaynor, Arrigo Schieppati, Mariantonia Serrano, Fernando de Andres, Nuria Sanz, Raquel Hernández, Germán Kreis, Charlotte Asker-Hagelberg, Hanna Johansson, Adeeba Asghar, Jean-Marc Husson, Jacques Demotes, Christian Gluud
Dátum:	2010
ISSN:	1745-6215
Megjegyzések:	BACKGROUND: 'Compassionate use' programmes allow medicinal products that are not authorised, but are in the development process, to be made available to patients with a severe disease who have no other satisfactory treatment available to them. We sought to understand how such programmes are regulated in ten European Union countries. METHODS: The European Clinical Research Infrastructures Network (ECRIN) conducted a comprehensive survey on clinical research regulatory requirements, including questions on regulations of 'compassionate use' programmes. Ten European countries, covering approximately 70% of the EU population, were included in the survey (Austria, Denmark, France, Germany, Hungary, Ireland, Italy, Spain, Sweden, and the UK). RESULTS: European Regulation 726/2004/EC is clear on the intentions of 'compassionate use' programmes and aimed to harmonise them in the European Union. The survey reveals that different countries have adopted different requirements and that 'compassionate use' is not interpreted in the same way across Europe. Four of the ten countries surveyed have no formal regulatory system for the programmes. We discuss the need for 'compassionate use' programmes and their regulation where protection of patients is paramount. CONCLUSIONS: 'Compassionate use' is a misleading term and should be replaced with 'expanded access'. There is a need for expanded access programmes in order to serve the interests of seriously ill patients who have no other treatment options. To protect these patients, European legislation needs to be more explicit and informative with regard to the regulatory requirements, restrictions, and responsibilities in expanded access programmes.
Tárgyszavak:	Orvostudományok Klinikai orvostudományok idegen nyelvű folyóiratközlemény külföldi lapban egyetemen (Magyarországon) készült közlemény
Megjelenés:	Trials. - 11 (2010), p. 104. -
További szerzők:	Huemer, Karl-Heinz Winter, Diana Thirstrup, Steffen Libersa, Christian Barraud, Béatrice Kubiak, Christine Stankovski, Lea Grählert, Xina Dreier, Gabriele Geismann, Sebastian Kuchinke, Wolfgang Strenge-Hesse, Anke Temesvári Zsuzsa Kardos Gabriella O'Brien, Timothy Cooney, Margaret Gaynor, Siobhan Schieppati, Arrigo Serrano, Mariantonia Andres-Trelles, Fernando de Sanz, Nuria Hernandez, Raquel Kreis, German Asker-Hagelberg, Charlotte Johansson, Hanna Asghar, Adeeba Husson, Jean-Marc Demotes-Mainard, Jacques Gluud, Christian Blaskó György (1947-) (belgyógyász, klinikai farmakológus)
Internet cím:	Intézményi repozitóriumban (DEA) tárolt változat DOI
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