The eBooks we sell are sold as a single-user licence and are intended for the end user only.
The sale of some eBooks are restricted to certain countries. To alert you to such restrictions, please select the country of the billing address of your credit or debit card you wish to use for payment.
For further information see https://www.wildy.com/ebook-formats
Once the order is confirmed an e-mail will be sent to you to allow you to download the eBook. For UK purchases this will be automatic. For purchases outside the UK a member of staff will need to confirm the sale. (Staff are available to do this during normal business hours, Mon-Fri 8:30-17:00 UK time)
All eBooks are supplied firm sale and cannot be returned. If you believe there is a fault with your eBook then contact us on ebooks@wildy.com and we will help in resolving the issue. This does not affect your statutory rights.
Due to a technical issue some ebooks are not available to order.
The book provides a concise overview of currently applicable regulatory frameworks of states which are among the world leaders in research and development (R&D) of cell and gene therapies.
Developments in genome editing are expected to lead to new possibilities for the treatment of hereditary diseases in humans. The treatment of such often severe but hitherto uncurable diseases can be based on genome-edited induced pluripotent stem cells (iPS cells). Such treatments constitute combined cell/gene therapies. These therapies need to be governed by a regulatory framework which ensures quality, safety, and efficacy of the relevant therapeutic products. On the other hand, such regulations may retard product approval and impede R&D. Accordingly, national regulations for therapies based on genome-edited iPS cells are an important and, as the case may be, decisive factor for both researchers and industry regarding their decision where to locate their R&D activities. Therefore, regulatory frameworks impact significantly on the competitiveness of states and their economies.
This is why a comparative analysis of laws and regulations of different countries matters. Such a comparative legal analysis provides an important insight into regulatory concepts which, in turn, may inspire adjustments of, or amendments to, domestic legal regimes. For this purpose, experts present country reports on France, Germany, Japan, South Korea, Switzerland, and the USA. The reports on France and Germany also refer to the parameters and implications arising from pertinent EU law. This contributed volume is aimed at researchers, but also at, e.g., legal scholars, lawmakers, regulators, and political decision makers.
