This book compares national and centralised procedure practices and key performance metrics, including current approval times, review practices and pharmacovigilance standards, in the seven Gulf States. Opportunities for an improved regulatory system are identified, which, if fully implemented, could have a significant impact on patients' access to new medicines. The Persian Gulf represents the next growth market for the global biopharmaceutical industry but to date there has been limited information about the regulatory review processes employed in these countries. A thorough examination of the strategies currently being implemented by the Gulf States is considered critical to the future regulatory environment in this region. Pharmaceutical Regulatory Environment: Challenges & Opportunities in the Gulf Region is a must read for those interested in pharmaceutical regulation in the Gulf region.

Design and Spirituality examines the philosophical context of our current situation and argues for a re-establishment and re-affirmation of self-transcending priorities, together with an ethos of moderation and sufficiency. It covers a wide range of topics broadly related to the main theme, including material culture and spiritual teachings; sustainability and the spiritual perspective; traditional and indigenous knowledge; technology and spirituality; notions of meaningful design; and the deeper, symbolic significance of (some) material things. The author is a leading thinker in the field and he presents his arguments in a manner that invites the reader to reflect and to think about where we are going, why we are going there and what really matters.

Design and Spirituality examines the philosophical context of our current situation and argues for a re-establishment and re-affirmation of self-transcending priorities, together with an ethos of moderation and sufficiency. It covers a wide range of topics broadly related to the main theme, including material culture and spiritual teachings; sustainability and the spiritual perspective; traditional and indigenous knowledge; technology and spirituality; notions of meaningful design; and the deeper, symbolic significance of (some) material things. The author is a leading thinker in the field and he presents his arguments in a manner that invites the reader to reflect and to think about where we are going, why we are going there and what really matters.

To advance the subject of design one has to engage in the activity of designing. Sustainable by Design offers a compelling and innovative, design-centred approach that explores both the meaning and practice of sustainable design. Walker explores the design process in the context of sustainability, and challenges conventional ways of defining, designing and producing functional objects. He discusses the personal design process, tacit knowledge, ephemeral design, experimental design, and the relationship between intellectual design criteria, physical expression and aesthetic experience.This book will introduce vital concepts to students and will inspire designers by providing a well-articulated basis for understanding the complexity and potential of sustainable design, and extolling the contribution of design to the creation of a more meaningful material culture.

Design Realities explores a wide range of topics on creativity, design and spiritual well-being. Using critique, rational inquiry and personal reflection, Stuart Walker looks squarely at our contemporary condition, demonstrates how current assumptions and material expectations are becoming untenable and, most importantly, offers constructive new directions that are feasible, spiritually enriching, and hopeful. Comprising short essays, lyrical pieces, photo studies and longer discourses, this book takes us on a highly readable and enjoyable journey through some of the most pressing issues of our time. The innovative, intuitive format makes these topics readily accessible, while providing much food for thought about the changing nature of creativity in today's world. Written by a leading thinker in the field, this highly original book offers readers something to ponder, discuss, contest and build upon.

Stuart Walker's design work has been described as life-changing, inspiring, disturbing and ferocious. Drawing on an extraordinarily diverse range of sources and informed by creative practice, Design for Life penetrates to the heart of modern culture and the malaise that underlies today's moral and environmental crises. The author argues that this malaise is deep-seated and fundamental to the modern outlook. He shows how our preoccupation with technological progress, growth and the future has produced a constricted view of life - one that is both destructive and self-reinforcing. Based on over twenty-five years of scholarship and creative practice, he demonstrates the vital importance of solitude, contemplation, inner growth and the present moment in developing a different course - one that looks squarely at our current, precarious situation while offering a positive, hopeful way forward - a way that is compassionate, context-based, human scale, ethically motivated and critically creative. Design for Life is an intensely original contribution that will be essential reading for design practitioners and students. Written in a clear, accessible style, it will also appeal to a broader readership, especially anyone who is concerned with contemporary society's rising inequalities and environmental failings and is looking for a more constructive, balanced and thoughtful direction.

Design Roots provides a comprehensive review of culturally significant designs, products and practices which are rooted to particular communities through making tradition and a sense of place. Many rich traditional practices associated with community, tacit knowledge and culture are being rapidly lost due to globalisation and urbanisation. Yet they have much to offer for the future in terms of sustainability, identity, wellbeing and new opportunities in design. This book considers the creative roots, the place-based ecologies, and deep understandings of cultural significance, not only in terms of history and tradition but also in terms of locale, social interactions, innovation, and change for the sustainment of culturally significant material productions. Importantly, these are not locked in time by sentimentality and nostalgia but are evolving, innovative, and adaptive to new technologies and changing circumstances. Contributing authors explore the historical roots of culturally significant designs, products and practices, emerging directions, amateur endeavours, enterprise models, business opportunities and the changing role and contribution of design in the creation of material cultures of significance, meaning and value. An international perspective is provided through case studies and research from North and South America, Africa, Europe, Asia and Australasia, with examples including Aran jumper production in Northern Ireland, weaving in Thailand, Iranian housing design, Brazilian street design and digital crafting in the United Kingdom.

This book proposes and investigates a universal framework, and accompanying documentation system, to facilitate and catalogue benefit-risk decisions; a valuable addition to the benefit-risk toolbox. Over the past decade, pharmaceutical companies and regulatory agencies have been reviewing the benefit-risk assessment of medicines with a view to developing a structured, systematic, standardized approach. Examining the evaluation of such an approach by several mature regulatory authorities ensures that the reader gains a unique insight into the ongoing debate in this area. The field of benefit-risk assessment continues to evolve at a rapid pace due to political and societal pressure, as is reflected in the recent FDA PUDFA agreement as well as in the EMA 2015 Roadmap. Rather than provide a comprehensive snap-shot of this constantly changing environment, this book evaluates selected current approaches to benefit-risk assessment. The strengths and weaknesses of publicly available documents in communicating benefit-risk decisions to stakeholders are reviewed and these evaluations are used to inform development of a prospective framework that could be used to harmonise procedures globally.

This book proposes and investigates a universal framework, and accompanying documentation system, to facilitate and catalogue benefit-risk decisions; a valuable addition to the benefit-risk toolbox. Over the past decade, pharmaceutical companies and regulatory agencies have been reviewing the benefit-risk assessment of medicines with a view to developing a structured, systematic, standardized approach. Examining the evaluation of such an approach by several mature regulatory authorities ensures that the reader gains a unique insight into the ongoing debate in this area. The field of benefit-risk assessment continues to evolve at a rapid pace due to political and societal pressure, as is reflected in the recent FDA PUDFA agreement as well as in the EMA 2015 Roadmap. Rather than provide a comprehensive snap-shot of this constantly changing environment, this book evaluates selected current approaches to benefit-risk assessment. The strengths and weaknesses of publicly available documents in communicating benefit-risk decisions to stakeholders are reviewed and these evaluations are used to inform development of a prospective framework that could be used to harmonise procedures globally.

This book compares national and centralised procedure practices and key performance metrics, including current approval times, review practices and pharmacovigilance standards, in the seven Gulf States. Opportunities for an improved regulatory system are identified, which, if fully implemented, could have a significant impact on patients’ access to new medicines. The Persian Gulf represents the next growth market for the global biopharmaceutical industry but to date there has been limited information about the regulatory review processes employed in these countries. A thorough examination of the strategies currently being implemented by the Gulf States is considered critical to the future regulatory environment in this region. Pharmaceutical Regulatory Environment: Challenges & Opportunities in the Gulf Region is a must read for those interested in pharmaceutical regulation in the Gulf region.

To advance the subject of design one has to engage in the activity of designing. Sustainable by Design offers a compelling and innovative, design-centred approach that explores both the meaning and practice of sustainable design. Walker explores the design process in the context of sustainability, and challenges conventional ways of defining, designing and producing functional objects. He discusses the personal design process, tacit knowledge, ephemeral design, experimental design, and the relationship between intellectual design criteria, physical expression and aesthetic experience. This book will introduce vital concepts to students and will inspire designers by providing a well-articulated basis for understanding the complexity and potential of sustainable design, and extolling the contribution of design to the creation of a more meaningful material culture.

Imaginative design will be a crucial factor in enacting sustainability in people's daily lives. Yet current design practice is trapped in consumerist cycles of innovation and production, making it difficult to imagine how we might develop a more meaningful and sustainable rendition of material culture.

Through fundamental design research, The Spirit of Design challenges a host of common assumptions about sustainability, progress, growth and globalization. Walker's practice-based explorations of localisation, human meaning and functional objects demonstrate the imaginative potential of research-through-design and yield a compelling, constructive and essentially hopeful direction for the future - one that radically re-imagines our material culture by meshing mass-production with individuality, products with place, and utilitarian benefit with environmental responsibility. In so doing, the author explores:

• how understandings of human meaning affect design and how design can better incorporate issues of personal meaning
• how mass production needs to become integrated with localised production and service provision
• how short-lived electronic goods can be brought into a more sustainable design paradigm
• the changing role of the designer in a post-consumerist world taking a design-centred approach
• a combination of creative, propositional design practice, reasoned argument and theoretical discussion
• the book will impel readers to investigate the nature of contemporary material culture and its relationship to both the natural environment and to deeper notions of human meaning.

What is the relationship between design, sustainability, inner values and spirituality? How can we create designs that provide a convincing alternative to unsustainable interpretations of progress, growth, consumerism and commercialism? Building on the arguments first advanced in his widely acclaimed books Sustainable by Design and The Spirit of Design, Stuart Walker explains how we can achieve the systemic changes needed to address the challenges of sustainability. Challenging common assumptions about the nature of our contemporary material culture and its relationship to human flourishing, the author introduces approaches to design that draw inspiration from nature, summon the human imagination and create outcomes which are environmentally responsible and socially just, as well as meaningful and enriching at a personal level. Offering a unique and original contribution to this vital debate, Designing Sustainability is destined to become essential reading for students on courses in design and sustainability and for design practitioners looking for a deeper, more meaningful basis for their work.

Design Realities explores a wide range of topics on creativity, design and spiritual well-being. Using critique, rational inquiry and personal reflection, Stuart Walker looks squarely at our contemporary condition, demonstrates how current assumptions and material expectations are becoming untenable and, most importantly, offers constructive new directions that are feasible, spiritually enriching, and hopeful. Comprising short essays, lyrical pieces, photo studies and longer discourses, this book takes us on a highly readable and enjoyable journey through some of the most pressing issues of our time. The innovative, intuitive format makes these topics readily accessible, while providing much food for thought about the changing nature of creativity in today's world. Written by a leading thinker in the field, this highly original book offers readers something to ponder, discuss, contest and build upon.

Design Roots provides a comprehensive review of culturally significant designs, products and practices which are rooted to particular communities through making tradition and a sense of place. Many rich traditional practices associated with community, tacit knowledge and culture are being rapidly lost due to globalization and urbanization. Yet they have much to offer for the future in terms of sustainability, identity, wellbeing and new opportunities in design. This book considers the creative roots, the place-based ecologies, and deep understandings of cultural significance, not only in terms of history and tradition but also in terms of locale, social interactions, innovation, and change for the sustainment of culturally significant material productions. Importantly, these are not locked in time by sentimentality and nostalgia but are evolving, innovative, and adaptive to new technologies and changing circumstances. Contributing authors explore the historical roots of culturally significant designs, products and practices, emerging directions, amateur endeavours, enterprise models, business opportunities and the changing role and contribution of design in the creation of material cultures of significance, meaning and value. An international perspective is provided through case studies and research from North and South America, Africa, Europe, Asia and Australasia, with examples including Aran jumper production in Northern Ireland, weaving in Thailand, Iranian housing design, Brazilian street design and digital crafting in the United Kingdom.

What is the relationship between design, sustainability, inner values and spirituality? How can we create designs that provide a convincing alternative to unsustainable interpretations of progress, growth, consumerism and commercialism? Building on the arguments first advanced in his widely acclaimed books Sustainable by Design and The Spirit of Design, Stuart Walker explains how we can achieve the systemic changes needed to address the challenges of sustainability. Challenging common assumptions about the nature of our contemporary material culture and its relationship to human flourishing, the author introduces approaches to design that draw inspiration from nature, summon the human imagination and create outcomes which are environmentally responsible and socially just, as well as meaningful and enriching at a personal level. Offering a unique and original contribution to this vital debate, Designing Sustainability is destined to become essential reading for students on courses in design and sustainability and for design practitioners looking for a deeper, more meaningful basis for their work.

This scarce antiquarian book is included in our special Legacy Reprint Series. In the interest of creating a more extensive selection of rare historical book reprints, we have chosen to reproduce this title even though it may possibly have occasional imperfections such as missing and blurred pages, missing text, poor pictures, markings, dark backgrounds and other reproduction issues beyond our control. Because this work is culturally important, we have made it available as a part of our commitment to protecting, preserving and promoting the world's literature.

This Is A New Release Of The Original 1919 Edition.