Chapter title |
Regulation of Clinical Trials with Advanced Therapy Medicinal Products in Germany
|
---|---|
Chapter number | 5 |
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_5 |
Pubmed ID | |
Book ISBNs |
978-3-31-918617-7, 978-3-31-918618-4
|
Authors |
Matthias Renner, Brigitte Anliker, Ralf Sanzenbacher, Silke Schuele, Renner, Matthias, Anliker, Brigitte, Sanzenbacher, Ralf, Schuele, Silke |
Abstract |
In the European Union, clinical trials for Advanced Therapy Medicinal Products are regulated at the national level, in contrast to the situation for a Marketing Authorisation Application, in which a centralised procedure is foreseen for these medicinal products. Although based on a common understanding regarding the regulatory requirement to be fulfilled before conduct of a clinical trial with an Advanced Therapy Investigational Medicinal Product, the procedures and partly the scientific requirements for approval of a clinical trial application differ between the European Union Member States. This chapter will thus give an overview about the path to be followed for a clinical trial application and the subsequent approval process for an Advanced Therapy Investigational Medicinal Product in Germany and will describe the role of the stakeholders that are involved. In addition, important aspects of manufacturing, quality control and non-clinical testing of Advanced Therapy Medicinal Products in the clinical development phase are discussed. Finally, current and future approaches for harmonisation of clinical trial authorisation between European Union Member States are summarised. |
Mendeley readers
Geographical breakdown
Country | Count | As % |
---|---|---|
Unknown | 27 | 100% |
Demographic breakdown
Readers by professional status | Count | As % |
---|---|---|
Student > Master | 5 | 19% |
Student > Ph. D. Student | 5 | 19% |
Student > Doctoral Student | 3 | 11% |
Student > Bachelor | 3 | 11% |
Professor | 2 | 7% |
Other | 5 | 19% |
Unknown | 4 | 15% |
Readers by discipline | Count | As % |
---|---|---|
Medicine and Dentistry | 6 | 22% |
Pharmacology, Toxicology and Pharmaceutical Science | 3 | 11% |
Biochemistry, Genetics and Molecular Biology | 3 | 11% |
Social Sciences | 3 | 11% |
Engineering | 2 | 7% |
Other | 6 | 22% |
Unknown | 4 | 15% |