Harmonisation of Regulatory Oversight in Biotechnology Biosafety and the Environmental Uses of Micro-Organisms Conference Proceedings

Harmonisation of Regulatory Oversight in Biotechnology Biosafety and the Environmental Uses of Micro-Organisms Conference Proceedings

Author: OECD

Publisher: OECD Publishing

Published: 2015-01-22

Total Pages: 223

ISBN-13: 9264213562

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These proceedings discuss the use of micro-organisms in agriculture and for production purposes such as bio-fuel, their use for bioremediation and in cleaning products, the environmental applications of insects, and environmental risk/safety assessment considerations.


Harmonisation of Regulatory Oversight in Biotechnology Safety Assessment of Transgenic Organisms in the Environment, Volume 8 OECD Consensus Document of the Biology of Mosquito Aedes aegypti

Harmonisation of Regulatory Oversight in Biotechnology Safety Assessment of Transgenic Organisms in the Environment, Volume 8 OECD Consensus Document of the Biology of Mosquito Aedes aegypti

Author: OECD

Publisher: OECD Publishing

Published: 2018-06-23

Total Pages: 138

ISBN-13: 9264302239

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Volume 8 of the Series contains the first biosafety ‘consensus document’ to deal with the biology of an insect, the mosquito Aedes aegypti. Issued by the OECD Working Group on the Harmonisation of Regulatory Oversight in Biotechnology, the science-based consensus documents...


Harmonisation of Regulatory Oversight in Biotechnology Safety Assessment of Transgenic Organisms in the Environment, Volume 7 OECD Consensus Documents

Harmonisation of Regulatory Oversight in Biotechnology Safety Assessment of Transgenic Organisms in the Environment, Volume 7 OECD Consensus Documents

Author: OECD

Publisher: OECD Publishing

Published: 2017-12-21

Total Pages: 246

ISBN-13: 9264279725

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Volume 7 describes the biology of two major crops: TOMATO and SORGHUM (centres of origin, genetics, hybridisation, production, uses, ecology) and an animal species: ATLANTIC SALMON (ecology, rearing and genetics for 'wild' and 'farmed' forms). It contains useful information for biosafety assessment.


Harmonisation of Regulatory Oversight in Biotechnology Safety Assessment of Transgenic Organisms in the Environment, Volume 9 OECD Consensus Documents on the Biology of Crops: Apple, Safflower, Rice

Harmonisation of Regulatory Oversight in Biotechnology Safety Assessment of Transgenic Organisms in the Environment, Volume 9 OECD Consensus Documents on the Biology of Crops: Apple, Safflower, Rice

Author: OECD

Publisher: OECD Publishing

Published: 2022-05-03

Total Pages: 223

ISBN-13: 9264983449

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Volume 9 of the Series compiles the biosafety consensus documents developed by the OECD Working Party on the Harmonisation of Regulatory Oversight in Biotechnology from 2019 to 2021. It deals with the biology of APPLE, SAFFLOWER and RICE, three important crops for agriculture and consumption worldwide.


Regulation of Genome Editing in Plant Biotechnology

Regulation of Genome Editing in Plant Biotechnology

Author: Hans-Georg Dederer

Publisher: Springer

Published: 2019-08-16

Total Pages: 379

ISBN-13: 3030171191

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This book provides in-depth insights into the regulatory frameworks of five countries and the EU concerning the regulation of genome edited plants. The country reports form the basis for a comparative analysis of the various national regulations governing genetically modified organisms (GMOs) in general and genome edited plants in particular, as well as the underlying regulatory approaches.The reports, which focus on the regulatory status quo of genome edited plants in Argentina, Australia, Canada, the EU, Japan and the USA, were written by distinguished experts following a uniform structure. On this basis, the legal frameworks are compared in order to foster a rational assessment of which approaches could be drawn upon to adjust, or to completely realign, the current EU regime for GMOs. In addition, a separate chapter identifies potential best practices for the regulation of plants derived from genome editing.


Regulatory Aspects of Gene Therapy and Cell Therapy Products

Regulatory Aspects of Gene Therapy and Cell Therapy Products

Author: Maria Cristina Galli

Publisher: Springer

Published: 2015-09-15

Total Pages: 235

ISBN-13: 3319186183

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This book discusses the different regulatory pathways for gene therapy (GT) and cell therapy (CT) medicinal products implemented by national and international bodies throughout the world (e.g. North and South America, Europe, and Asia). Each chapter, authored by experts from various regulatory bodies throughout the international community, walks the reader through the applications of nonclinical research to translational clinical research to licensure for these innovative products. More specifically, each chapter offers insights into fundamental considerations that are essential for developers of CT and GT products, in the areas of product manufacturing, pharmacology and toxicology, and clinical trial design, as well as pertinent "must-know" guidelines and regulations. Regulatory Aspects of Gene Therapy and Cell Therapy Products: A Global Perspective is part of the American Society of Gene and Cell Therapy sub-series of the highly successful Advances in Experimental Medicine and Biology series. It is essential reading for graduate students, clinicians, and researchers interested in gene and cell therapy and the regulation of pharmaceuticals.