| Chapter title |
Requirements for Clinical Trials with Gene Therapy and Transplant Products in Switzerland
|
|---|---|
| Chapter number | 7 |
| Book title |
Regulatory Aspects of Gene Therapy and Cell Therapy Products
|
| Published in |
Advances in experimental medicine and biology, January 2015
|
| DOI | 10.1007/978-3-319-18618-4_7 |
| Pubmed ID | |
| Book ISBNs |
978-3-31-918617-7, 978-3-31-918618-4
|
| Authors |
Andreas Marti, Marti, Andreas |
| Abstract |
This chapter aims to describe and summarize the regulation of gene and cell therapy products in Switzerland and its legal basis. Product types are briefly described, as are Swiss-specific terminologies such as the term "transplant product," which means products manufactured from cells, tissues, or even whole organs. Although some parts of this chapter may show a guideline character, they are not legally binding, but represent the current thinking of Swissmedic, the Swiss Agency for Therapeutic Products. As so far the experience with marketing approval of gene therapy and cell therapy products in Switzerland is limited, this chapter focuses on the regulation of clinical trials conducted with these products. Quality, nonclinical, and clinical aspects are summarized separately for gene therapy products and transplant products. |
Mendeley readers
Geographical breakdown
| Country | Count | As % |
|---|---|---|
| Unknown | 26 | 100% |
Demographic breakdown
| Readers by professional status | Count | As % |
|---|---|---|
| Student > Ph. D. Student | 5 | 19% |
| Student > Bachelor | 4 | 15% |
| Researcher | 3 | 12% |
| Student > Doctoral Student | 2 | 8% |
| Student > Postgraduate | 2 | 8% |
| Other | 4 | 15% |
| Unknown | 6 | 23% |
| Readers by discipline | Count | As % |
|---|---|---|
| Medicine and Dentistry | 9 | 35% |
| Engineering | 2 | 8% |
| Nursing and Health Professions | 2 | 8% |
| Pharmacology, Toxicology and Pharmaceutical Science | 1 | 4% |
| Biochemistry, Genetics and Molecular Biology | 1 | 4% |
| Other | 4 | 15% |
| Unknown | 7 | 27% |