This book provides a comprehensive overview of FDA (Federal Drug Administration) procedures. It simplifies the complexities involved in getting FDA clearance by using an integrated approach of clinical, engineering, and business aspects. It includes both medical devices and drug development. This involves understanding the structure of the FDA, its purpose, and its initiatives. This book also examines what is needed for designing clinical trials and addressing recalls and failures. It uses case studies to further illustrate the integrated method stressed throughout this work.

The twenty-first century witnessed a new age of whistleblowing in the United States. Disclosures by Chelsea Manning, Edward Snowden, and others have stoked heated public debates about the ethics of exposing institutional secrets, with roots in a longer history of state insiders revealing privileged information. Bringing together contributors from a range of disciplines to consider political, legal, and cultural dimensions, Whistleblowing Nation is a pathbreaking history of national security disclosures and state secrecy from World War I to the present. The contributors explore the complex politics, motives, and ideologies behind the revelation of state secrets that threaten the status quo, challenging reductive characterizations of whistleblowers as heroes or traitors. They examine the dynamics of state retaliation, political backlash, and civic contests over the legitimacy and significance of the exposure and the whistleblower. The volume considers the growing power of the executive branch and its consequences for First Amendment rights, the protection and prosecution of whistleblowers, and the rise of vast classification and censorship regimes within the national-security state. Featuring analyses from leading historians, literary scholars, legal experts, and political scientists, Whistleblowing Nation sheds new light on the tension of secrecy and transparency, security and civil liberties, and the politics of truth and falsehood.

Das Buch bietet eine umfassende Darstellung der finanzkrisenbedingten gesetzgeberischen Entwicklungen im Bereich der Vorstandsvergutung und der damit einhergehenden juristischen Probleme. Insbesondere auf dem Gebiet der aktuellen Vergutungsregulierung werden neue und fur die Praxis brauchbare Loesungsansatze herausgearbeitet. Die Vielzahl der in den letzten Jahren erlassenen Neuregelungen bzw. AEnderungen hat ein besonderes Augenmerk der Legislative, Exekutive, aber auch der OEffentlichkeit auf diese Aspekte gelenkt. Die Autorin stellt unter anderem dar, inwieweit die Neuregelungen zu einer AEnderung des bisherigen Unternehmensalltags beitragen und somit eine praktische Umsetzung erfahren. Die Zusammensetzung der Managervergutung sowohl in Deutschland als auch in Grossbritannien und den USA erfahrt eine ausfuhrliche Auseinandersetzung.

Vividly depicting the process of therapy, this instructive casebook presents in-depth illustrations of treatment based on the most important couple therapy models. An array of leading clinicians offer a window onto how they work with clients grappling with mild and more serious clinical concerns, including conflicts surrounding intimacy, sex, power, and communication; parenting issues; and mental illness. Featuring couples of varying ages, cultural backgrounds, and sexual orientations, the cases shed light on both what works and what doesn't work when treating intimate partners. Each candid case presentation includes engaging comments and discussion questions from the editor.

The twenty-first century witnessed a new age of whistleblowing in the United States. Disclosures by Chelsea Manning, Edward Snowden, and others have stoked heated public debates about the ethics of exposing institutional secrets, with roots in a longer history of state insiders revealing privileged information. Bringing together contributors from a range of disciplines to consider political, legal, and cultural dimensions, Whistleblowing Nation is a pathbreaking history of national security disclosures and state secrecy from World War I to the present. The contributors explore the complex politics, motives, and ideologies behind the revelation of state secrets that threaten the status quo, challenging reductive characterizations of whistleblowers as heroes or traitors. They examine the dynamics of state retaliation, political backlash, and civic contests over the legitimacy and significance of the exposure and the whistleblower. The volume considers the growing power of the executive branch and its consequences for First Amendment rights, the protection and prosecution of whistleblowers, and the rise of vast classification and censorship regimes within the national-security state. Featuring analyses from leading historians, literary scholars, legal experts, and political scientists, Whistleblowing Nation sheds new light on the tension of secrecy and transparency, security and civil liberties, and the politics of truth and falsehood.

Beginning with the Cold War and concluding with the 2003 invasion of Iraq, Hannah Gurman explores the overlooked opposition of U.S. diplomats to American foreign policy in the latter half of the twentieth century. During America's reign as a dominant world power, U.S. presidents and senior foreign policy officials largely ignored or rejected their diplomats' reports, memos, and telegrams, especially when they challenged key policies relating to the Cold War, China, and the wars in Vietnam and Iraq. "The Dissent Papers" recovers these diplomats' invaluable perspective and their commitment to the transformative power of diplomatic writing.

Gurman showcases the work of diplomats whose opposition enjoyed some success. George Kennan, John Stewart Service, John Paton Davies, George Ball, and John Brady Kiesling all caught the attention of sitting presidents and policymakers, achieving temporary triumphs yet ultimately failing to change the status quo. Gurman follows the circulation of documents within the State Department, the National Security Council, the C.I.A., and the military, and she details the rationale behind "The Dissent Channel," instituted by the State Department in the 1970s, to both encourage and contain dissent. Advancing an alternative narrative of modern U.S. history, she connects the erosion of the diplomatic establishment and the weakening of the diplomatic writing tradition to larger political and ideological trends while, at the same time, foreshadowing the resurgent significance of diplomatic writing in the age of Wikileaks.

Topics discussed: Wedding Photography, Photo Ideas and descriptions for re production, Portrait Photography, Corporate Photography, Children Photography, Animals and pets photography, Birthday Photography, Fashion Photography, Model Photography, Photography at night, General Photography questions, Business of Photography, Film Making, Music Clip Making Advice for Models how to start, how to build a Model career in NYC, USA, advice from models to models. Retouch people advice, advice from models and retouch people for photographers via their eyes. How to find models to work with for photographers. Legal document samples: Contract with photographer and film maker, Contract with Fashion designer, Contract with a Model, contract with potential client for wedding photography and videography, Contract with Wardrobe, Hair and Make Up people, property release, Model release, 2257 form, photo shoot sample outline, what to bring with you to the photo shoot.

This volume contains the proceedings of the IFAC Workshop on "Singular Solutions and Perturbations in Control Systems "(SSPCS-97) held at Pereslavl-Zalessky, Russia on 7-11 July 1997. The Workshop was sponsored by IFAC and organized jointly by the Russian National Committee of Automatic Control, the Program Systems Institute and the Institute for Information Transmission Problems at the Russian Academy of Sciences, and the University of Pereslavl.

The objective of this workshop was to provide an international forum for the discussion of recent developments and advances in the fields of singular control problems, impulsive control, singular perturbations technique in control systems, computational problems and others.

The Workshop was devoted both to theoretical and applicative aspects of the so-called "nonclassical" problems in the area of control theory, such as problems with singular perturbations, impulse and generalized controls. These problems arise in various areas of applications, including mechanics, information processing, medicine and economy. At the same time they stimulate the development of new mathematical tools in the classical theory of control and differential equations.

All papers included in this volume are given in the form presented by the authors.

Vividly depicting the process of therapy, this instructive casebook presents in-depth illustrations of treatment based on the most important couple therapy models. An array of leading clinicians offer a window onto how they work with clients grappling with mild and more serious clinical concerns, including conflicts surrounding intimacy, sex, power, and communication; parenting issues; and mental illness. Featuring couples of varying ages, cultural backgrounds, and sexual orientations, the cases shed light on both what works and what doesn't work when treating intimate partners. Each candid case presentation includes engaging comments and discussion questions from the editor.

Based on the 'soft path' approach to the energy sector, a transition is now under way to a soft path for water. This approach starts by ensuring that ecosystem needs for water are satisfied and then undertakes a radical approach to reducing human uses of water by economic and social incentives, including open decision-making, water markets and equitable pricing, and the application of super-efficient technology, all applied in ways that avoid jeopardizing quality of life. The soft path for water is therefore a management strategy that frees up water by curbing water waste.

Making the Most of the Water We Have is the first to present and apply the water soft path approach. It has three aims:

• to bring to a wider audience the concept and the potential of water soft paths
• to demonstrate that soft path analysis is analytical and practical, and not just 'eco-dreaming'
• to indicate that soft paths are not only conceptually attractive but that they can be made economically and politically feasible.

Includes a tool kit for planners and other practitioners.

Published with POLIS Project and Friends of the Earth

Integrating the clinical and engineering aspects of drug delivery, this book offers a much needed comprehensive overview and patient-oriented approach for enhanced drug delivery optimization and advancement. Starting with an introduction to the subject and pharmacokinetics, it explores advances for such topics as oral, gastroretentive, intravitreal, and intrathecal drug delivery, as well as insulin delivery, gene delivery, and biomaterials-based delivery systems. It also describes drug delivery in cancer, cardiac, infectious diseases, airway diseases, and obstetrics and gynecology applications. Examining special clinical states requiring innovative drug delivery modifications, such as hypercoagulability often seen in pregnancy, cancer, and autoimmune diseases, the book also discusses methods for improved drug delivery in clinical settings using clinical end points, clinical trials, simulations, and other venues. It also describes the latest drug delivery advances involving nanomaterials, NEMS and MEMS devices, hydrogels, microencapsulation, lipids, stem cells, patches, and ultrasound. The book is rounded out by a chapter on the FDA regulatory and bioethical challenges involved in advancing drug delivery.

Based on the 'soft path' approach to the energy sector, a transition is now under way to a soft path for water. This approach starts by ensuring that ecosystem needs for water are satisfied and then undertakes a radical approach to reducing human uses of water by economic and social incentives, including open decision-making, water markets and equitable pricing, and the application of super-efficient technology, all applied in ways that avoid jeopardizing quality of life. The soft path for water is therefore a management strategy that frees up water by curbing water waste. Making the Most of the Water We Have is the first to present and apply the water soft path approach. It has three aims: to bring to a wider audience the concept and the potential of water soft paths to demonstrate that soft path analysis is analytical and practical, and not just 'eco-dreaming' to indicate that soft paths are not only conceptually attractive but that they can be made economically and politically feasible. Includes a tool kit for planners and other practitioners. Published with POLIS Project and Friends of the Earth