NDLI: Tissue engineering and Eucomed news in brief

Content Provider	IEEE Xplore Digital Library
Author	Papadaki, M.
Copyright Year	1983
Description	This study emphasizes the importance of multicellular cultures in providing appropriate signals for vascular organization of skeletal tissues. Eucomed, the European Medical Technology Industry Association, represents directly and indirectly more than 3,500 business entities in Europe and beyond. The Eucomed mission is to create and maintain a suitable framework by enabling the manufacturers of medical technology and other related economic actors to operate, innovate, and market in an open and competitive marketplace, with the ultimate objective to improve the access of patients and clinicians to modern and reliable medical technology products. The paper shows a recent example of the role of Eucomed on the tissue engineering industry as illustrated in its response to the proposal of a regulation launched by the European Commission on 4 May 2005. The proposal covers human-tissue-engineered products, bringing them under the scope of medicinal products. Eucomed's position is that since human-tissue-engineering products are not medicinal products, they cannot be regulated by the existing, unchanged rules for medicinal products. Existing requirements for clinical investigation and for good manufacturing practices for medicinal products should be appropriately adapted from the technical point of view, while maintaining their general ethical requirements. Eucomed has also put forward suggestions to address the specificity of combination products, in particular hybrid products made of human-tissue-engineered products and medical devices.
File Size	51103
Starting Page	91
File Format	PDF
ISSN	07395175
Volume Number	25
Issue Number	3
Language	English
Publisher	Institute of Electrical and Electronics Engineers, Inc. (IEEE)
Publisher Date	2006-05-01
Publisher Place	U.S.A.
Access Restriction	Subscribed
Rights Holder	Institute of Electrical and Electronics Engineers, Inc. (IEEE)
Subject Keyword	Tissue engineering Muscles In vitro Implants Musculoskeletal system Europe Embryo Fibroblasts Manufacturing industries Research and development
Content Type	Text
Resource Type	Article
Subject	Biomedical Engineering

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1	Ministry of Education (GoI), Department of Higher Education	Sanctioning Authority	https://www.education.gov.in/ict-initiatives
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4	Project PI / Joint PI	Principal Investigator and Joint Principal Investigators of the project	Dr. B. Sutradhar bsutra@ndl.gov.in Prof. Saswat Chakrabarti will be added soon
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