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Saturday, August 18, 2018 2:46:33 PM
Commercialisation of Advanced Therapies.
A Study of the EU Regulation on Advanced Therapy Medical Products
Faculty of Law University of Helsinki
Helsinki 2016
"The primary objective of this study is to analyse the benefits and limitations of the ATMP Regulation from the perspective of SMEs, academia and non-profit organisations that develop ATMPs. Secondly, it discusses the kind of amendment to the ATMP Regulation and related regulatory instruments and processes required to accelerate translation of research into advanced therapies and to facilitate commercialisation of ATMPs whilst ensuring the safety of patients. In addition, it analyses implications of the EU s limited mandate in the field of public health for developers of ATMPs. This study also investigates whether barriers to commercialisation relate to ATMPs as such or whether something else in the innovation system is impeding their market entry. As an example of potential ATMPs undergoing development, it also considers some specific, regulatory and moral patenting obstacles that impede the market entry of human embryonic stem cell-based products."
https://helda.helsinki.fi/bitstream/handle/10138/166228/Commerci.pdf?sequence=3&isAllowed=y
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