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Literature and Guidance Documents

Gene therapy bio-safety: scientific and regulatory issues. Gene Ther 2005; 12: S146–152. This paper discusses the topics during the round table of the 2nd European Conference & Practical Course: Towards Clinical Gene Therapy: Preclinical Gene Transfer Assessment, held in Bellaterra (Spain), 1–14 February, 2004.

Opinion paper on the current status of the regulation of gene therapy in Europe. Hum. Gene Ther. 2002; 13:2085-110. A summary description of the current regulatory status of gene therapy in each European country is provided in order to emphasize the requirement for standardization and therefore foster the development of gene therapy. This description is followed by consensus comments and recommendations of the Euregenethy Network.

Analysis of the applicability of the contained use legislation for clinical trials (2006). Perseus BVBA. This report is the result of an initiative of the European Commission to perform an analysis of the applicability of the contained use legislation for clinical trials. The objectives of the project were to collect and prepare background information and data concerning clinical trials and the suitability of the legislation under which they are governed, and to undertake a detailed appraisal of the current legislation in terms of the suitability and adequacy of their provisions to address the potential risks from clinical trials.

European Association of Hospital Pharmacists (EAHP) Guidance on the Pharmacy Handling of Gene Medicines. EJHP 2007; 5: 29 -39. This guidance for the handling of gene medicines specifies the requirements for each step in the process from storage, dispensing and administration to the disposal of all materials involved in handling such therapeutic agents.

Environmental risk assessment of replication competent viral vectors in gene therapy trials (RIVM rapport 601850001; 2008). The Netherlands National Institute for Public Health and the Environment (RIVM) has developed a method to estimate the risks for man and the environment of the application of replication competent viral vectors in cancer therapy. Since such a method did not exist, this report will be a significant aid in the risk assessment of replication competent viruses and in guiding applications for a gene therapy license involving the use of these viruses through the regulatory process in the Netherlands. Supplementary document: Overview of replication competent viral vectors (RIVM rapport 601850002; 2008).