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Survey about Regulation on Gene Therapy in Some European Countries

Research output: Contributions to collected editions/works › Chapter

Standard

Survey about Regulation on Gene Therapy in Some European Countries. / Simon, Jürgen W.
Interdisciplinary Approaches to Gene Therapy: Legal, Ethical and Scientific Aspects. ed. / Stefan Müller; Jürgen W. Simon; Jan W. Vesting. Berlin, Heidelberg: Springer, 1997. p. 129-136.

Research output: Contributions to collected editions/works › Chapter

Harvard

Simon, JW 1997, Survey about Regulation on Gene Therapy in Some European Countries. in S Müller, JW Simon & JW Vesting (eds), Interdisciplinary Approaches to Gene Therapy: Legal, Ethical and Scientific Aspects. Springer, Berlin, Heidelberg, pp. 129-136. https://doi.org/10.1007/978-3-642-60829-2_13

APA

Simon, J. W. (1997). Survey about Regulation on Gene Therapy in Some European Countries. In S. Müller, J. W. Simon, & J. W. Vesting (Eds.), Interdisciplinary Approaches to Gene Therapy: Legal, Ethical and Scientific Aspects (pp. 129-136). Springer. https://doi.org/10.1007/978-3-642-60829-2_13

Vancouver

Simon JW. Survey about Regulation on Gene Therapy in Some European Countries. In Müller S, Simon JW, Vesting JW, editors, Interdisciplinary Approaches to Gene Therapy: Legal, Ethical and Scientific Aspects. Berlin, Heidelberg: Springer. 1997. p. 129-136 doi: 10.1007/978-3-642-60829-2_13

Bibtex

@inbook{362899e88dc640f9a504ef4c135bdb66,
title = "Survey about Regulation on Gene Therapy in Some European Countries",
abstract = "Gene therapeutic products are classed as drugs in Italy in accordance with Art. 1 of the decree to adapt the EEC-guidelines in the area of pharmaceutical specialities1. In the area of gene therapy, clinical trials and courses of treatment are not specifically differentiated. One talks only about a „clinical experiment``2. Art. 12 p. 3 Codice di Deontologia medica (CDM) reserves the use of new treatments for clinical trials. This, however, is not a compulsory regulation; the drug law also has no rules applied to clinical trials. Therefore, a single course of treatment, in accordance with the spirit of German law, is possible, but at the same time practically unnecessary due to the unclear boundaries for clinical trials.",
keywords = "Law, Gene Therapy, Gene Technology, Ethic Commision, National control, biological safety",
author = "Simon, {J{\"u}rgen W.}",
year = "1997",
doi = "10.1007/978-3-642-60829-2_13",
language = "English",
isbn = "978-3-540-63056-2",
pages = "129--136",
editor = "Stefan M{\"u}ller and Simon, {J{\"u}rgen W.} and Vesting, {Jan W.}",
booktitle = "Interdisciplinary Approaches to Gene Therapy",
publisher = "Springer",
address = "Germany",

}

RIS

TY - CHAP

T1 - Survey about Regulation on Gene Therapy in Some European Countries

AU - Simon, Jürgen W.

PY - 1997

Y1 - 1997

N2 - Gene therapeutic products are classed as drugs in Italy in accordance with Art. 1 of the decree to adapt the EEC-guidelines in the area of pharmaceutical specialities1. In the area of gene therapy, clinical trials and courses of treatment are not specifically differentiated. One talks only about a „clinical experiment``2. Art. 12 p. 3 Codice di Deontologia medica (CDM) reserves the use of new treatments for clinical trials. This, however, is not a compulsory regulation; the drug law also has no rules applied to clinical trials. Therefore, a single course of treatment, in accordance with the spirit of German law, is possible, but at the same time practically unnecessary due to the unclear boundaries for clinical trials.

AB - Gene therapeutic products are classed as drugs in Italy in accordance with Art. 1 of the decree to adapt the EEC-guidelines in the area of pharmaceutical specialities1. In the area of gene therapy, clinical trials and courses of treatment are not specifically differentiated. One talks only about a „clinical experiment``2. Art. 12 p. 3 Codice di Deontologia medica (CDM) reserves the use of new treatments for clinical trials. This, however, is not a compulsory regulation; the drug law also has no rules applied to clinical trials. Therefore, a single course of treatment, in accordance with the spirit of German law, is possible, but at the same time practically unnecessary due to the unclear boundaries for clinical trials.

KW - Law

KW - Gene Therapy

KW - Gene Technology

KW - Ethic Commision

KW - National control

KW - biological safety

UR - https://www.mendeley.com/catalogue/214b9a92-8f7b-3734-bed2-6792af11657f/

U2 - 10.1007/978-3-642-60829-2_13

DO - 10.1007/978-3-642-60829-2_13

M3 - Chapter

SN - 978-3-540-63056-2

SP - 129

EP - 136

BT - Interdisciplinary Approaches to Gene Therapy

A2 - Müller, Stefan

A2 - Simon, Jürgen W.

A2 - Vesting, Jan W.

PB - Springer

CY - Berlin, Heidelberg

ER -

DOI