Bone marrow gene transfer in three patients with adenosine deaminase deficiency
Hoogerbrugge PM, van Beusechem VW, Fischer A, et al. Bone marrow gene transfer in three patients with adenosine deaminase deficiency. Gene Ther 1996; 3: 179-183.
Commission of the European Communities (2001). Directive 2001/20/EC of the European Parliament and of the Council of 4 April 2001 on the approximation of the laws, regulations and administrative provisions of the Member States relating to the implementation of good clinical practice in the conduct of clinical trials on medicinal products for human use (Official Journal L 121, 1/5/2001 p. 34-44).
Commission of the European Communities (2001). Directive 2001/20/EC of the European Parliament and of the Council of 4 April 2001 on the approximation of the laws, regulations and administrative provisions of the Member States relating to the implementation of good clinical practice in the conduct of clinical trials on medicinal products for human use (Official Journal L 121, 1/5/2001 p. 34-44).
3
35148900653
Commission of the European Communities (2001). Directive 2001/18/EC of the European Parliament and of the Council of 12 March 2001 on the deliberate release into the environment of genetically modified organisms and repealing Council Directive 90/220/EEC (Official Journal L 106, 17/4/2001 p. 1-39).
Commission of the European Communities (2001). Directive 2001/18/EC of the European Parliament and of the Council of 12 March 2001 on the deliberate release into the environment of genetically modified organisms and repealing Council Directive 90/220/EEC (Official Journal L 106, 17/4/2001 p. 1-39).
4
35148885057
Commission of the European Communities (1998). Council Directive 98/81/ EC of 26 October 1998 amending Directive 90/219/EEC on the contained use of genetically modified micro-organisms (Official Journal L 330, 5/12/ 1998 p. 13-31).
Commission of the European Communities (1998). Council Directive 98/81/ EC of 26 October 1998 amending Directive 90/219/EEC on the contained use of genetically modified micro-organisms (Official Journal L 330, 5/12/ 1998 p. 13-31).
5
0011835106
Gene therapy in Germany and in Europe: Regulatory issues
Cichutek K, Krämer I. Gene therapy in Germany and in Europe: regulatory issues. Qual Assur J 1997; 2: 141-152.
Euregenethy Network. Opinion paper on the current status of the regulation of gene therapy in Europe
Cohen-Haguenauer O, Rosenthal F, Gansbacher B, et al. Euregenethy Network. Opinion paper on the current status of the regulation of gene therapy in Europe. Hum Gene Ther 2002; 13: 2085-2110.
Analysis of the applicability of the contained use legislation for clinical trials 2006; Perseus BVBA.
Analysis of the applicability of the contained use legislation for clinical trials 2006; Perseus BVBA.
8
35148899460
Commission of the European Communities (2001). Directive 2001/83/EC of the European Parliament and of the Council of 6 November 2001 on the Community code relating to medicinal products for human use (Official Journal L 311, 28/11/2001 p. 67-128).
Commission of the European Communities (2001). Directive 2001/83/EC of the European Parliament and of the Council of 6 November 2001 on the Community code relating to medicinal products for human use (Official Journal L 311, 28/11/2001 p. 67-128).
9
35148839995
Commission of the European Communities. (2004). Regulation (EC) No 726/ 2004 of the European Parliament and of the Council of 31 March 2004 laying down Community procedures for the authorisation and supervision of medicinal products for human and veterinary use and establishing a European Medicines Agency (Official Journal L 136, 30/4/2004 p. 1-33).
Commission of the European Communities. (2004). Regulation (EC) No 726/ 2004 of the European Parliament and of the Council of 31 March 2004 laying down Community procedures for the authorisation and supervision of medicinal products for human and veterinary use and establishing a European Medicines Agency (Official Journal L 136, 30/4/2004 p. 1-33).
10
0038690170
Regulatory issues in human gene therapy
Cornetta K. Regulatory issues in human gene therapy. Blood Cells Mol Dis 2003; 31: 51-56.