The Animal By-Products and Transmissible Spongiform Encephalopathies (England) (Amendment) (EU Exit) Regulations 2018

The Animal By-Products and Transmissible Spongiform Encephalopathies (England) (Amendment) (EU Exit) Regulations 2018 PDF Author: Great Britain
Publisher:
ISBN: 9780111174012
Category :
Languages : en
Pages :

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Book Description
Enabling power: European Union (Withdrawal) Act 2018, s. 8 (1). Issued: 05.11.2018. Sifted: 23.10.2018. Made: 29.10.2018. Laid: 30.10.2018. Coming into force: Om accord. with reg. 1. Effect: S.I. 2013/2952; 2018/731 amended. Territorial extent & classification: E. General. EC note: These Regulations amend domestic legislation that provides enforcement of: (a) the Transmissible Spongiform Encephalopathies Regulation (EC) No 999/2001 laying down rules for the prevention, control and eradication of certain transmissible spongiform encephalopathies,(b) the Animal By-Product Regulation (EC) No 1069/2009 laying down health rules as regards animal by-products and derived products not intended for human consumption, and (c) Commission Regulation (EU) No 142/2011 implementing Regulation (EC) No 1069/2009

The Animal By-Products and Transmissible Spongiform Encephalopathies (England) (Amendment) (EU Exit) Regulations 2018

The Animal By-Products and Transmissible Spongiform Encephalopathies (England) (Amendment) (EU Exit) Regulations 2018 PDF Author: Great Britain
Publisher:
ISBN: 9780111174012
Category :
Languages : en
Pages :

Get Book Here

Book Description
Enabling power: European Union (Withdrawal) Act 2018, s. 8 (1). Issued: 05.11.2018. Sifted: 23.10.2018. Made: 29.10.2018. Laid: 30.10.2018. Coming into force: Om accord. with reg. 1. Effect: S.I. 2013/2952; 2018/731 amended. Territorial extent & classification: E. General. EC note: These Regulations amend domestic legislation that provides enforcement of: (a) the Transmissible Spongiform Encephalopathies Regulation (EC) No 999/2001 laying down rules for the prevention, control and eradication of certain transmissible spongiform encephalopathies,(b) the Animal By-Product Regulation (EC) No 1069/2009 laying down health rules as regards animal by-products and derived products not intended for human consumption, and (c) Commission Regulation (EU) No 142/2011 implementing Regulation (EC) No 1069/2009

Safe Management of Wastes from Health-care Activities

Safe Management of Wastes from Health-care Activities PDF Author: Yves Chartier
Publisher: World Health Organization
ISBN: 9241548568
Category : Medical
Languages : en
Pages : 327

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Book Description
This is the second edition of the WHO handbook on the safe, sustainable and affordable management of health-care waste--commonly known as "the Blue Book". The original Blue Book was a comprehensive publication used widely in health-care centers and government agencies to assist in the adoption of national guidance. It also provided support to committed medical directors and managers to make improvements and presented practical information on waste-management techniques for medical staff and waste workers. It has been more than ten years since the first edition of the Blue Book. During the intervening period, the requirements on generators of health-care wastes have evolved and new methods have become available. Consequently, WHO recognized that it was an appropriate time to update the original text. The purpose of the second edition is to expand and update the practical information in the original Blue Book. The new Blue Book is designed to continue to be a source of impartial health-care information and guidance on safe waste-management practices. The editors' intention has been to keep the best of the original publication and supplement it with the latest relevant information. The audience for the Blue Book has expanded. Initially, the publication was intended for those directly involved in the creation and handling of health-care wastes: medical staff, health-care facility directors, ancillary health workers, infection-control officers and waste workers. This is no longer the situation. A wider range of people and organizations now have an active interest in the safe management of health-care wastes: regulators, policy-makers, development organizations, voluntary groups, environmental bodies, environmental health practitioners, advisers, researchers and students. They should also find the new Blue Book of benefit to their activities. Chapters 2 and 3 explain the various types of waste produced from health-care facilities, their typical characteristics and the hazards these wastes pose to patients, staff and the general environment. Chapters 4 and 5 introduce the guiding regulatory principles for developing local or national approaches to tackling health-care waste management and transposing these into practical plans for regions and individual health-care facilities. Specific methods and technologies are described for waste minimization, segregation and treatment of health-care wastes in Chapters 6, 7 and 8. These chapters introduce the basic features of each technology and the operational and environmental characteristics required to be achieved, followed by information on the potential advantages and disadvantages of each system. To reflect concerns about the difficulties of handling health-care wastewaters, Chapter 9 is an expanded chapter with new guidance on the various sources of wastewater and wastewater treatment options for places not connected to central sewerage systems. Further chapters address issues on economics (Chapter 10), occupational safety (Chapter 11), hygiene and infection control (Chapter 12), and staff training and public awareness (Chapter 13). A wider range of information has been incorporated into this edition of the Blue Book, with the addition of two new chapters on health-care waste management in emergencies (Chapter 14) and an overview of the emerging issues of pandemics, drug-resistant pathogens, climate change and technology advances in medical techniques that will have to be accommodated by health-care waste systems in the future (Chapter 15).

Social policy in the European Union: state of play 2015

Social policy in the European Union: state of play 2015 PDF Author: David Natali (OSE)
Publisher: ETUI
ISBN: 2874523747
Category : European Union countries
Languages : en
Pages : 298

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Book Description
The sixteenth edition of Social policy in the European Union: state of play has a triple ambition. First, it provides easily accessible information to a wide audience about recent developments in both EU and domestic social policymaking. Second, the volume provides a more analytical reading, embedding the key developments of the year 2014 in the most recent academic discourses. Third, the forward-looking perspective of the book aims to provide stakeholders and policymakers with specific tools that allow them to discern new opportunities to influence policymaking. In this 2015 edition of Social policy in the European Union: state of play, the authors tackle the topics of the state of EU politics after the parliamentary elections, the socialisation of the European Semester, methods of political protest, the Juncker investment plan, the EU’s contradictory education investment, the EU’s contested influence on national healthcare reforms, and the neoliberal Trojan Horse of the Transatlantic Trade and Investment Partnership (TTIP).

How to Prevent the Next Pandemic

How to Prevent the Next Pandemic PDF Author: Bill Gates
Publisher: Vintage
ISBN: 0593534492
Category : Health & Fitness
Languages : en
Pages : 235

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Book Description
Governments, businesses, and individuals around the world are thinking about what happens after the COVID-19 pandemic. Can we hope to not only ward off another COVID-like disaster but also eliminate all respiratory diseases, including the flu? Bill Gates, one of our greatest and most effective thinkers and activists, believes the answer is yes. The author of the #1 New York Times best seller How to Avoid a Climate Disaster lays out clearly and convincingly what the world should have learned from COVID-19 and what all of us can do to ward off another catastrophe like it. Relying on the shared knowledge of the world’s foremost experts and on his own experience of combating fatal diseases through the Gates Foundation, Gates first helps us understand the science of infectious diseases. Then he shows us how the nations of the world, working in conjunction with one another and with the private sector, how we can prevent a new pandemic from killing millions of people and devastating the global economy. Here is a clarion call—strong, comprehensive, and of the gravest importance.

Yogurt in Health and Disease Prevention

Yogurt in Health and Disease Prevention PDF Author: Nagendra P. Shah
Publisher: Academic Press
ISBN: 0128052724
Category : Medical
Languages : en
Pages : 572

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Book Description
Yogurt in Health and Disease Prevention examines the mechanisms by which yogurt, an important source of micro- and macronutrients, impacts human nutrition, overall health, and disease. Topics covered include yogurt consumption’s impact on overall diet quality, allergic disorders, gastrointestinal tract health, bone health, metabolic syndrome, diabetes, obesity, weight control, metabolism, age-related disorders, and cardiovascular health. Modifications to yogurt are also covered in scientific detail, including altering the protein to carbohydrate ratios, adding n-3 fatty acids, phytochemical enhancements, adding whole grains, and supplementing with various micronutrients. Prebiotic, probiotic, and synbiotic yogurt component are also covered to give the reader a comprehensive understanding of the various impacts yogurt and related products can have on human health. Health coverage encompasses nutrition, gastroenterology, endocrinology, immunology, and cardiology Examines novel and unusual yogurts as well as popular and common varieties Covers effects on diet, obesity, and weight control Outlines common additives to yogurts and their respective effects Reviews prebiotics, probiotics, and symbiotic yogurts Includes practical information on how yogurt may be modified to improve its nutritive value

National Trade Estimate ... Report on Foreign Trade Barriers

National Trade Estimate ... Report on Foreign Trade Barriers PDF Author: United States. Office of the U.S. Trade Representative
Publisher:
ISBN:
Category : Commercial policy
Languages : en
Pages : 408

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Book Description


Biosimilars

Biosimilars PDF Author: Hiten J. Gutka
Publisher: Springer
ISBN: 3319996800
Category : Medical
Languages : en
Pages : 713

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Book Description
This book provides a comprehensive overview of the biosimilar regulatory framework, the development process and clinical aspects for development of biosimilars. The development path of a biosimilar is just as unique as a development path of a new drug, tailored by the mechanism of action, the quality of the molecule, published information on the reference product, the current competitive environment, the target market and regulatory guidance, and most importantly, the emerging totality of evidence for the proposed biosimilar during development. For the ease of readers, the book comprises of six sections as follows: Section I: Business, Health Economics and Intellectual Property Landscape for Biosimilars Section II: Regulatory Aspects of Development and Approval for Biosimilars Section III: Biopharmaceutical Development and Manufacturing of Biosimilars Section IV: Analytical Similarity Considerations for Biosimilars Section V: Clinical aspects of Biosimilar Development Section VI: Biosimilars- Global Development and Clinical Experience Chapters have been written by one or more experts from academia, industry or regulatory agencies who have been involved with one or more aspects of biosimilar product development. The authors and editors have an expertise in commercialization and pricing of biosimilars, intellectual property considerations for biosimilars, chemistry manufacturing controls (CMC) and analytical development for biosimilars, regulatory and clinical aspects of biosimilar development. Besides the industry practitioners, the book includes several contributions from regulators across the globe.

Prevention and Control of Infections in Hospitals

Prevention and Control of Infections in Hospitals PDF Author: Bjørg Marit Andersen
Publisher: Springer
ISBN: 3319999214
Category : Medical
Languages : en
Pages : 1090

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Book Description
This volume offers extensive information on preventive and infection surveillance procedures, routines and policies adapted to the optimal infection control level needed to tackle today’s microbes in hospital practice. It especially focuses on preventive measures for serious hospital infections. Each chapter includes a practical section that addresses the main aspects of procedures and treatment, and a theoretical section that contains updated documentation that can be used for further study, or to help select infection control measures. Infection control concerns all healthcare professional working directly or indirectly with patients; in diagnosis, treatment, isolation measures, operations, equipment, drugs, cleaning, textiles, transport, porter service, food and water, building and maintenance, etc. Hygiene and environmental control is central to infection prevention for patients, visitors and staff alike. Good hygienic practices, individual infection control, well implemented and frequent environmental cleaning, and a high professional standard of hygiene in the treatment and care of patients, are essential to patient safety and a safe working environment. Addressing this essential topic, this book is intended for doctors, nurses and other healthcare workers, students in health-related subjects, hospital managers and health bureaucrats, as well as patients and their families.

The Challenge of CMC Regulatory Compliance for Biopharmaceuticals

The Challenge of CMC Regulatory Compliance for Biopharmaceuticals PDF Author: John Geigert
Publisher: Springer
ISBN: 3030137546
Category : Medical
Languages : en
Pages : 426

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Book Description
Biopharmaceuticals (i.e., biological medicines sourced from genetically-engineered living systems) for treatment of human diseases have become a significant percentage of the pharmaceutical industry. And not just the recombinant DNA-derived proteins and monoclonal antibodies (both from the innovators and biosimilars); but now, an increasing awareness of the importance of gene therapy and genetically engineered cellular medicinal products. These biopharmaceuticals are being developed by many companies whose Chemistry, Manufacturing & Control (CMC) teams have varying degrees of familiarity or experience with the CMC strategy and regulatory compliance requirements for these challenging products. Companies clearly plan out the strategy for their clinical study plans, but frequently, the development of a strategy for CMC is an afterthought. Coupled with the complexity of the biopharmaceutical manufacturing processes and products, and this can be a recipe for disaster. The third edition of this book provides insights and practical guidance for the CMC teams to develop an acceptable cost-effective, risk-based CMC regulatory compliance strategy for all biopharmaceuticals (recombinant proteins, monoclonal antibodies, genetically engineered viruses and genetically engineered human cells) from early clinical stage development through market approval. The third edition of this book provides added coverage for the biosimilars, antibody drug conjugates (ADCs), bispecific antibodies, genetically engineered viruses, and genetically engineered cells. This third edition of the book also addresses the heightened pressure on CMC regulatory compliance timelines due to the introduction of expedited clinical pathways moving the clinical development closer to a seamless phase process (e.g., FDA Breakthrough Therapy designation, CBER Regenerative Medicine Advanced Therapy (RMAT) designation, EMA Priority Medicines (PRIME) designation). The Challenge of CMC Regulatory Compliance for Biopharmaceuticals is essential, practical information for all pharmaceutical development scientists, Manufacturing and Quality Unit staff, Regulatory Affairs personnel, and senior management involved in the manufacture of biopharmaceuticals.

WHO Expert Committee on Biological Standardization

WHO Expert Committee on Biological Standardization PDF Author: WHO Expert Committee on Biological Standardization. Meeting
Publisher:
ISBN: 9789241209328
Category : Medical
Languages : en
Pages : 137

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Book Description
The Committee reports on general issues discussed and provides information on the status and development of reference materials for various antibodies, antigens, blood products and related substances, cytokines, growth factors and endocrinological substances. The second part of the report, of particular relevance to manufacturers and national regulatory authorities, contains guidelines on the production and quality control of candidate tetravalent dengue virus vaccines and recommendations for the preparation, characterisation and establishment of international and other biological reference standards.