Universität zu Köln

Schmael, Christine, Becker, Katja ORCID: 0000-0003-4858-5127, Berg, Ruth, Bruenger, Michael, Lehmkuhl, Gerd, Oehler, Klaus-Ulrich, Ruppert, Thorsten, Staudter, Claus, Trott, Goetz-Erik and Dittmann, Ralf W. (2014). Pediatric Psychopharmacological Research in the Post EU Regulation 1901/2006 Era Is There a Will and a Way? Experience and Perspectives of Lay and Expert Representatives in Germany. Z. Kinder-und Jugendpsy. Psychother., 42 (6). S. 441 - 450. BERN 9: VERLAG HANS HUBER. ISSN 1664-2880

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Abstract

Although the use of psychotropic medications in child and adolescent psychiatry in Germany is on the increase, most compounds are in fact prescribed off-label because of a lack of regulatory approval in these age groups. In 2007, the European Parliament introduced Regulation 1901/2006 concerning medicinal products in pediatric populations, with a subsequent amendment in the form of Regulation 1902/2006. The main aim of this legislation was to encourage research and clinical trials in children and adolescents, and thus promote the availability of medications with marketing authorization for these age groups. Furthermore, initiatives such as the European 7th Framework Program of the European Union now offer substantial funding for pediatric pharmacological research. At a recent Congress of the German Society for Child and Adolescent Psychiatry and Psychotherapy (DGKTP), experts from the field and the pharmaceutical industry held a symposium with lay representatives in order to discuss attitudes toward, and experience with, pediatric psychopharmacology research in Germany since 2007. Several areas of concern were identified. The present paper derives from that symposium and provides an overview of these opinions, which remain crucial to the field. A wider discussion of how to facilitate psychopharmacological research in Germany in order to optimize the treatment and welfare of children and adolescents with psychiatric disorders is now warranted.

Item Type:	Journal Article
Creators:	Creators Email ORCID ORCID Put Code Schmael, Christine UNSPECIFIED UNSPECIFIED UNSPECIFIED Becker, Katja UNSPECIFIED orcid.org/0000-0003-4858-5127 UNSPECIFIED Berg, Ruth UNSPECIFIED UNSPECIFIED UNSPECIFIED Bruenger, Michael UNSPECIFIED UNSPECIFIED UNSPECIFIED Lehmkuhl, Gerd UNSPECIFIED UNSPECIFIED UNSPECIFIED Oehler, Klaus-Ulrich UNSPECIFIED UNSPECIFIED UNSPECIFIED Ruppert, Thorsten UNSPECIFIED UNSPECIFIED UNSPECIFIED Staudter, Claus UNSPECIFIED UNSPECIFIED UNSPECIFIED Trott, Goetz-Erik UNSPECIFIED UNSPECIFIED UNSPECIFIED Dittmann, Ralf W. UNSPECIFIED UNSPECIFIED UNSPECIFIED
URN:	urn:nbn:de:hbz:38-424037
DOI:	10.1024/1422-4917/a000322
Journal or Publication Title:	Z. Kinder-und Jugendpsy. Psychother.
Volume:	42
Number:	6
Page Range:	S. 441 - 450
Date:	2014
Publisher:	VERLAG HANS HUBER
Place of Publication:	BERN 9
ISSN:	1664-2880
Language:	English
Faculty:	Unspecified
Divisions:	Unspecified
Subjects:	no entry
Uncontrolled Keywords:	Keywords Language MEDICATIONS; DISORDER Multiple languages Psychiatry Multiple languages
URI:	http://kups.ub.uni-koeln.de/id/eprint/42403