Download or read book Guidance on Dossier and Substance Evaluation written by European Chemicals Agency and published by . This book was released on 2007 with total page 139 pages. Available in PDF, EPUB and Kindle. Book excerpt: This document describes the evaluation tasks to be performed by the Authorities: evaluation of testing proposals and compliance check by the Agency and substance evaluation by the Member States Competent Authorities.
Download or read book How to Communicate with ECHA in Dossier Evaluation written by and published by . This book was released on 2015 with total page 27 pages. Available in PDF, EPUB and Kindle. Book excerpt: The purpose of this Practical Guide 12 is to explain, in simple terms, what dossier evaluation is, how the dossiers are processed under dossier evaluation and to highlight the opportunities and obligations that registrants have in making sure that their dossiers are compliant with the REACH Regulation. This guide also explains what kind of different administrative outcomes of dossier evaluation can be expected and how and when the registrants can react to communications received from ECHA. In brief, the REACH Regulation1 requires EU companies to submit registration dossiers for substances manufactured in or imported to the EU in quantities of one tonne or more per year. When a registration dossier is submitted, the European Chemicals Agency (ECHA) assigns a registration number once it has been confirmed that the dossier is complete. This completeness check of the registration dossier does not include an examination of the quality or the adequacy of the data submitted. The REACH Regulation states that such an assessment is carried out independently from the registration process, through a process called Evaluation (Title VI, Articles 40-54 of the REACH Regulation).
Download or read book How to Act in Dossier Evaluation written by and published by . This book was released on 2019 with total page pages. Available in PDF, EPUB and Kindle. Book excerpt: Practical guides aim to help duty holders - manufacturers, importers of substances, and only representatives - to fulfil their obligations in relation to the REACH Regulation. They provide practical tips and advice and explain the Agency's processes and scientific approaches. Practical guides are produced by ECHA, under its sole responsibility. They do not replace the formal Guidance, established under the formal guidance consultation process involving stakeholders, which provides the principles and interpretations needed for a thorough understanding of the requirements under REACH. The purpose of this practical guide is to explain in simple terms your duties regarding the content of your registration dossier and how the dossier is processed under dossier evaluation. The guide aims to give you and the other recipients of a draft or adopted decision information on how to act after receiving the decision. It also highlights the opportunities and obligations that you as registrants have in making sure that your dossier is compliant with the REACH Regulation. The guide also reminds you of your other obligations, such as data sharing, to make sure the information is generated in a reasonable manner and demonstrates the safe use of chemicals. Finally, the practical guide also provides advice and recommendations based on ECHA's experience with the dossier evaluation processes.
Download or read book Registrant s Guide written by and published by . This book was released on 2020 with total page pages. Available in PDF, EPUB and Kindle. Book excerpt: Practical Guides aim to help duty holders to fulfil their obligations in relation to the REACH Regulation (or "REACH"). They provide practical tips and advice and explain ECHA's processes and scientific approaches. Practical Guides are produced by ECHA, under its sole responsibility. They do not replace formal Guidance (which is established under the formal guidance consultation process involving stakeholders) that provides the principles and interpretations needed for a thorough understanding of the requirements of REACH. However, they explain, in a practical way, specific issues presented in the formal Guidance. ECHA invites interested parties to submit experiences and examples to be incorporated in future updates of this document. These can be submitted using the contact form. The purpose of this Practical Guide is to explain in simple terms what substance evaluation is, and how substances are selected and subsequently evaluated. This guide aims also to highlight the opportunities as well as the obligations that you, as a registrant, have in providing the information requested under substance evaluation. This guide describes (i) what kind of different administrative outcomes you can expect from the substance evaluation process and (ii) how and when you can react to communications received from an evaluating Member State competent authority (eMSCA) or from ECHA. This guide also addresses data sharing and communication between registrants of the same substance.
Download or read book Registrant s Guide written by and published by . This book was released on 2018 with total page 29 pages. Available in PDF, EPUB and Kindle. Book excerpt: Practical Guides aim to help duty holders to fulfil their obligations in relation to the REACH Regulation (or "REACH"). They provide practical tips and advice and explain ECHA's processes and scientific approaches. Practical Guides are produced by ECHA, under its sole responsibility. They do not replace the formal Guidance (which is established under the formal guidance consultation process involving stakeholders) that provides the principles and interpretations needed for a thorough understanding of the requirements of REACH. However, they explain, in a practical way, specific issues presented in the formal Guidance. ECHA invites interested parties to submit experiences and examples to be incorporated in future updates of this document. These can be submitted using the contact form1. The purpose of this practical guide is to explain in simple terms what substance evaluation (SEv) is, and how substances are selected and subsequently evaluated. This guide aims also to highlight the opportunities as well as the obligations that you, as registrant, have in providing the information requested under substance evaluation. This guide describes (i) what kind of different administrative outcomes you can expect from the substance evaluation process and (ii) how and when you can react to communications received from an evaluating Member State competent authority (eMSCA) and/or from ECHA. This guide also addresses data sharing and communication between registrants of the same substance.
Download or read book Guidance Documents written by and published by . This book was released on 199? with total page pages. Available in PDF, EPUB and Kindle. Book excerpt: Access to guidance documents that represent the Center's current thinking on a particular subject.
Download or read book OECD Series on Testing and Assessment Revised Guidance Document 150 on Standardised Test Guidelines for Evaluating Chemicals for Endocrine Disruption written by OECD and published by OECD Publishing. This book was released on 2018-09-03 with total page 692 pages. Available in PDF, EPUB and Kindle. Book excerpt: This guidance document was originally published in 2012 and updated in 2018 to reflect new and updated OECD test guidelines, as well as reflect on scientific advances in the use of test methods and assessment of the endocrine activity of chemicals.
Download or read book Containment Systems written by Nigel Hirst and published by IChemE. This book was released on 2002 with total page 224 pages. Available in PDF, EPUB and Kindle. Book excerpt: As the manufacture of new toxic pharmaceutical products grows, it is necessary to handle more compounds of increasing toxicity in the workplace. For this reason, and because the expectation of better employee protection and improved working procedures is growing, there is an increasing demand for better containment systems and a better understanding of those systems.
Download or read book Dietary Supplements written by United States. Federal Trade Commission. Bureau of Consumer Protection and published by . This book was released on 1998 with total page 32 pages. Available in PDF, EPUB and Kindle. Book excerpt:
Download or read book EU Chemicals Regulation written by Steven Vaughan and published by Edward Elgar Publishing. This book was released on 2015-07-31 with total page 279 pages. Available in PDF, EPUB and Kindle. Book excerpt: This perceptive book provides an exploratory, explanatory and normative account of the EU Regulation on the Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH), and its regulator, the European Chemicals Agency (ECHA). Ê W
Download or read book The European Union REACH Regulation for Chemicals written by Lucas Bergkamp and published by OUP Oxford. This book was released on 2013-10-24 with total page 489 pages. Available in PDF, EPUB and Kindle. Book excerpt: This book discusses the law and practice of the European Union's new chemical regulatory programmes known under the acronym ''REACH'. REACH is intended to ensure the safe management of risks associated with chemical substances throughout the supply chain. Its scope is very broad; subject to limited exceptions, REACH applies to all bulk chemicals used in industrial processes and to chemicals present in products such as cleaning products, paints, clothing, furniture, and electrical appliances. The newly established European Chemicals Agency (ECHA), the Commission, and member state authorities are in charge of administering the various parts of the REACH Regulation, creating a complex patchwork of government powers, procedures, and oversight. The volume is written by experienced REACH practitioners. It addresses both the key legal regulatory issues associated with REACH and the key management and practical challenges. In addition to analysing the scope, the processes, and the obligations of the industry under REACH, the book covers the strategy and management of REACH compliance from the perspective of the regulated entities. The focus is on the strategic and practical decisions facing companies subject to REACH's various regimes. Significant attention is paid to REACH consortia, which are a key instrument in compliance management, and to the competition law issues arising in connection with REACH consortia. It also covers legal remedies, enforcement, intellectual property rights, and civil liability for damages arising from chemical substances as well as how companies can shape their REACH compliance programme to reduce their liability exposure.
Download or read book A Comprehensive Guide to Toxicology in Preclinical Drug Development written by Ali S. Faqi and published by Academic Press. This book was released on 2012-10-18 with total page 903 pages. Available in PDF, EPUB and Kindle. Book excerpt: A Comprehensive Guide to Toxicology in Preclinical Drug Development is a resource for toxicologists in industry and regulatory settings, as well as directors working in contract resource organizations, who need a thorough understanding of the drug development process. Incorporating real-life case studies and examples, the book is a practical guide that outlines day-to-day activities and experiences in preclinical toxicology. This multi-contributed reference provides a detailed picture of the complex and highly interrelated activities of preclinical toxicology in both small molecules and biologics. The book discusses discovery toxicology and the international guidelines for safety evaluation, and presents traditional and nontraditional toxicology models. Chapters cover development of vaccines, oncology drugs, botanic drugs, monoclonal antibodies, and more, as well as study development and personnel, the role of imaging in preclinical evaluation, and supporting materials for IND applications. By incorporating the latest research in this area and featuring practical scenarios, this reference is a complete and actionable guide to all aspects of preclinical drug testing. - Chapters written by world-renowned contributors who are experts in their fields - Includes the latest research in preclinical drug testing and international guidelines - Covers preclinical toxicology in small molecules and biologics in one single source
Download or read book Final report for the NORAP Priority Setting Workshop written by Nordiska Ministerrådet and published by Nordic Council of Ministers. This book was released on 2010 with total page 134 pages. Available in PDF, EPUB and Kindle. Book excerpt:
Download or read book OECD Guidelines for the Testing of Chemicals OECD Series on Testing and Assessment Guidance Notes for Analysis and Evaluation of Chronic Toxicity and Carcinogenicity Studies written by OECD and published by OECD Publishing. This book was released on 2002-12-12 with total page 112 pages. Available in PDF, EPUB and Kindle. Book excerpt: These Guidance Notes outline core concepts in order to obviate the need to consult large numbers of text books, while still pointing the reader to sources of more detailed or specific information.
Download or read book OECD Guidelines for the Testing of Chemicals OECD Series on Testing and Assessment Guidance Notes for Analysis and Evaluation of Repeat Dose Toxicity Studies written by OECD and published by OECD Publishing. This book was released on 2002-05-10 with total page 87 pages. Available in PDF, EPUB and Kindle. Book excerpt: This document presents a general guide to the analysis and evaluation of data from studies involving repeated exposures of toxicity test species to pesticides and other chemicals.
Download or read book Diet and Health written by National Research Council and published by National Academies Press. This book was released on 1989-01-01 with total page 765 pages. Available in PDF, EPUB and Kindle. Book excerpt: Diet and Health examines the many complex issues concerning diet and its role in increasing or decreasing the risk of chronic disease. It proposes dietary recommendations for reducing the risk of the major diseases and causes of death today: atherosclerotic cardiovascular diseases (including heart attack and stroke), cancer, high blood pressure, obesity, osteoporosis, diabetes mellitus, liver disease, and dental caries.
Download or read book An Evidence Framework for Genetic Testing written by National Academies of Sciences, Engineering, and Medicine and published by National Academies Press. This book was released on 2017-04-21 with total page 149 pages. Available in PDF, EPUB and Kindle. Book excerpt: Advances in genetics and genomics are transforming medical practice, resulting in a dramatic growth of genetic testing in the health care system. The rapid development of new technologies, however, has also brought challenges, including the need for rigorous evaluation of the validity and utility of genetic tests, questions regarding the best ways to incorporate them into medical practice, and how to weigh their cost against potential short- and long-term benefits. As the availability of genetic tests increases so do concerns about the achievement of meaningful improvements in clinical outcomes, costs of testing, and the potential for accentuating medical care inequality. Given the rapid pace in the development of genetic tests and new testing technologies, An Evidence Framework for Genetic Testing seeks to advance the development of an adequate evidence base for genetic tests to improve patient care and treatment. Additionally, this report recommends a framework for decision-making regarding the use of genetic tests in clinical care.
