The Generic Challenge

Understanding Patents, FDA and Pharmaceutical Life-Cycle Management (Fifth Edition)

by Martin A. Voet

09/07/2016

This Fifth Edition of The Generic Challenge provides important new updates on current regulatory, legal and commercial issues affecting brand and generic pharmaceutical products, including new laws establishing generics for biologics, and changes brought about by the recently enacted America Invents Act. It explains clearly and understandably the roles of patents, FDA regulation of drugs and the Hatch Waxman Act in commercial drug development in light of generic challenges and how improvements in innovative drug products provide benefits to patients while extending the commercial lives of the drugs. There is simply no other book of its kind on this important subject.

Strategic Approaches to the Legal Environment of Business

A Game Theory Based Decision Making Guide for Managers

by Michael O'Brien, András Margitay-Becht

06/25/2018

Current and future managers are regularly confronted with decisions that create risk in the legal environment of business. This book provides a framework for qualifying legal risk and then determining if the legal risk is worth taking. This framework begins by looking at the relationship between the firm, its suppliers, customers, owners, agents, and others in society as a whole to understand specific risks in personal injury, agreements, products, borrowing money, employees, independent contractors, and business entity selection. When the manager is aware of the magnitude of the risk and the likelihood of the risk, the manager is in a strong position to determine if the risk is worth taking. This book uses numerous applications from Game Theory to determine how risks of the firm compare t...

Gapology

How Winning Leaders Close Performance Gaps, 5th Anniversary Edition

by Mark Thienes and Brian Brockhoff

03/23/2015

Gapology is the term Mark Thienes and Brian Brockhoff coined to describe what winning leaders do to identify and close performance gaps in their teams. Gapology is their process. For more than a decade, they analyzed the results, leadership behaviors and tactics of winning leaders as compared to those of leaders who were not winning. They wanted to understand how winning leaders win and if winning could be replicated. They were deeply curious about whether winning can be taught to those not winning or if winning leaders are simply born with the skills to win. As they interviewed and documented their conversations with winning leaders they found commonalities. The most amazing was that all performance gaps are either; Knowledge Gaps, Importance Gaps, Action Gaps, or some combination of the ...

Knowledge Management in Police Oversight

Law Enforcement Integrity and Accountability

by Petter Gottschalk

09/24/2009

Police oversight agencies are citizens' watchdog organizations designed to ensure that the police are operating with integrity and accountability. Integrity is defined as the quality of being honest and morally upright. Accountability refers to situations in which someone is required or expected to justify actions or decisions. Based on integrity and accountability challenges in police forces all over the world, this book discusses the roles and methods of police oversight agencies. Knowledge management in police oversight is presented by identifying knowledge categories and knowledge management systems. A model for police oversight performance is developed in the book, and the model is applied to an oversight agency as a case study. By the same author: White-Collar Crime: Detection...

Managing Bids, Tenders and Proposals

Introducing the Bid.Win.Deliver Framework

by James Noel Smith

09/14/2017

Managing Bids, Tenders and Proposals shows suppliers and vendors how they can gain competitive advantage by being more effective and productive when pursuing sales opportunities and competing to win new contracts. Suppliers and vendors can also learn how to identify and reduce delivery risk and commercial risk. Responding to requests-for-tenders (RFTs) and requests-for-proposals (RFPs) is frequently a challenging time for the supplier and vendor bid teams. Within tight timeframes, they must finalise their win strategy, determine their delivery plans and create compelling documentation that responds to the customer's questions and requirements. This essential reference work explores what needs to happen when responding to RFTs and RFPs and explains the essential knowledge needed by the bid...

The Temp Factor

The Complete Guide to Temporary Employment for Staffing Services, Clients, and Temps

by Cathy A. Reilly

08/13/2012

Temporary employment is on the rise. In uncertain economic times, many businesses view employing temps as a cost-effective strategy to both maximize productivity and foster flexibility. Being noticed and ultimately hired by clients in this increasingly competitive market requires staffing services and temps to perform at new levels of excellence. Working with staffing service firms and temps for over 20 years, Cathy A. Reilly has learned a thing or two about the staffing industry and the bottom line: what temporary employment success looks like to a client. No matter where you are in this three-sided working arrangement, The Temp Factor: The Complete Guide to Temporary Employment for Staffing Services, Clients, and Temps is the most comprehensive and innovative manual on temporary emplo...

The Knowledge-Based Economy

Modeled, Measured, Simulated

by Loet Leydesdorff

09/25/2006

How can an economy based on something as volatile as knowledge be sustained? The urgency of improving our understanding of a knowledge-based economy provides the context and necessity of this study. In a previous study entitled A Sociological Theory of Communications: The Self-Organization of the Knowledge-based Society (2001) the author specified knowledge-based systems from a sociological perspective. In this book, he takes this theory one step further and demonstrates how the knowledge base of an economic system can be operationalized, both in terms of measurement and by providing simulation models. The measurement instruments are applied to the German and Dutch economies and elaborated in terms of regional and sectorial differences. The knowledge base is specified in th...

Transfer Pricing

A Diagrammatic and Case Study Introduction, with Special Reference to China

by Alan Paisey & Jian Li

02/28/2012

This book offers an introduction to transfer pricing with particular reference to China, for those who are looking for an overview that can be rapidly comprehended and who value diagrammatic images as a vehicle for learning. The subject is of importance both for Chinese and foreign personnel engaged in foreign company activity in China and for those who are similarly engaged in Chinese-owned companies already operating abroad, or which are to be extended to foreign locations.

Integrating Financial Services Regulation

Exploring Some of the Challenges Posed by the EU Data Protection Regime

by Solomon Osagie

08/15/2018

The book charts the course and the history of how the regulation of financial services has evolved looking particularly at data protection. It addresses concepts like integration theory, the behaviour of nation-states when they attempt to forge geo-political unions and the implications and outcomes of state interaction in regulatory matters. Unlike many other General Data Protection Regulation (GDPR) publications in the market, it contains useful analyses of the GDPR but it does so in a very practical and informative way. It recognises the perspectives of various interests including academics and commercial organisations and presents the subject in a compelling, historical and easy to digest manner, starting with the challenges of integration that the EU has faced. It then charts the cours...

Introduction to Transport Economics

Demand, Cost, Pricing, and Adoption

by David J. Spurling

03/29/2010

Introduction to Transport Economics looks at the different modes of transport and investigates the past and present influences on their behaviour. The author's experience of teaching and working in the industry has led him to believe that it is difficult to understand the present without some knowledge of the past. He discusses the future of transport; in the light of climate change and likely fossil fuel shortages, it is important to have a clear idea of what we wish to achieve with a transport system. Also included are a chapter on developing countries, as well as a chapter about international transport as a whole. Too often transport has been a political shuttlecock without any long-term vision. Part of the aim of this book is to enable people who read it to have a greater idea of what...

The Business of Trademarks

A Practical Guide to Trademark Management for Attorneys and Paralegals

by Carol Chadirjian

04/23/2018

We come in contact with many trademarks each day on television, retail stores, Internet. The Business of Trademarks explains why trademarks are so important to businesses and how they identify the manufacturer and guarantee consistent quality to achieve brand loyalty. The Business of Trademarks is intended as a practical guide for those new to trademarks, including attorneys, paralegals and law students requiring a concise, comprehensive book on trademark prosecution to gain the skills and knowledge necessary to perform day-to-day trademark work diligently, confidently and with efficiency. Specific topics covered are:* Trademark searching for clearance* Forms to be filed with the Patent and Trademark Office* Famous trademarks and trade dress * Responding to office actions* Methods of enfor...

Policing Financial Crime

Intelligence Strategy Implementation

by Petter Gottschalk

11/30/2009

Policing Financial Crime presents theories of financial crime, stages of financial crime, and criminal entrepreneurship. Response, regulation, and prevention of financial crime are described in terms of police intelligence strategy, intelligence information sources, and information systems. By combining insights into the broad variety of financial crime types and behaviors and alternative law enforcement approaches, this book provides a unique insight into the growing local and global phenomena of financial crime. By the same author: White-Collar Crime: Detection, Prevention and Strategy in Business Enterprises Knowledge Management in Police Oversight: Law Enforcement Integrity and Accountability Essential Knowledge and Management Issues in Law Firms

Symbolic Innovations

Lessons from Health Services and Higher Education Organizations

by J. David Johnson

02/22/2017

Organizations are often rewarded for doing the trendy and flashy, as the recent fashionable university efforts related to Massively Open Online Course's demonstrate all too clearly. Innovations demonstrate many things symbolically to external stakeholders: you are on the cutting edge, you are the future, you are worthy of investment, you can respond to competitive pressures, you are attuned to a larger world, and so on. Ultimately, unfortunately, it is often not the work you do, but what your efforts stand for symbolically that is critical to evaluations of work performance. Here we will explore symbolic innovations comprehensively. Studying them provides a more thorough view of innovation processes and the underlying factors that motivate, generate them. Looking at innovations as sym...

A Practical Guide to Airline Customer Service

From Airline Operations to Passenger Services

by Colin C. Law

04/17/2018

A Practical Guide to Airline Customer Service is written for airline executives and undergraduate students who are preparing for a career in the airline service industry. Those working in similar functions and fields can also benefit from this book. This book primarily focuses on the importance of customer service in the airline industry. This includes basic airline operations and essential communication skills, and how airline service agents interact with passengers at every contact point of the travel process. It is a useful guide for anyone seeking a successful and rewarding career in the airline industry. REVIEWS Finally, there is a text that is both practical and useful, fit for training existing staff or use in the lecture hall to prepare future airline professionals! Colin Law h...

by Mark Thienes and Brian Brockhoff

04/29/2016

Mark Thienes and Brian Brockhoff discovered the pathway of transformation called IMBAR. Whether in your professional career, organization, personal life or any specific situation, leveraging your IDENTITY gives you the tremendous power to intentionally produce whatever RESULTS you desire. Our IDENTITY creates our MINDSET, BEHAVIOR, and ACTIONS culminating in our RESULTS...thus IMBAR! Here is an excerpt from a lecture given by Mark, where he describes IMBAR: "We are all wired for greatness. We are wired to achieve extraordinary things. The hardware is already installed in each of us. More than 90 percent of humans just let their lives play out. What happens just happens, and what will be will be. Somehow, the other 10 percent got a different user's manual, and it says that we ar...

Theory and Practice of Modern Islamic Finance

The Case Analysis from Australia

by Abu Umar Faruq Ahmad

12/29/2009

Theory and Practice of Modern Islamic Finance seeks to contribute to the existing body of work in the area of Islamic finance through examining the extent of divergence in practice of Islamic financing from the traditional Shari`ah in the Australian context. The author makes a discursive analysis of the regulation of Islamic finance in Australia in terms of (a) the financing instruments used, (b) certainty of transactions between participants in the system, and (c) institutional risk management of Islamic financial institutions. The work's objectives are two-fold: (a) to analytically study the extent to which Islamic Financial Services Providers (IFSPs) of Australia differ from the traditional Shari`ah in their current practices of Islamic legal financial system by their use of different f...

Risk Factors and Business Models

Understanding the Five Forces of Entrepreneurial Risk and the Causes of Business Failure

by D. Anthony Miles

05/18/2011

One of the primary concerns in a small business is the problem of risk. Many who begin the start-up process terminate it in less than one year. Of those that survive, many are unable to achieve sustained growth and profits. Small-to-medium business enterprises (SME) have a 50% to 90% chance of failure within the first five years. While there are measures of personal risk behavior of entrepreneurs, the literature contains no measure of risk orientation for the enterprise. The purpose of this study was to develop and validate a researcher-designed instrument to measure the critical forces of business risk. The 37-item Entrepreneurial Risk Assessment Scale (ERAS) was developed from key theoretical concepts grounded in economics, marketing, management, finance, and entrepreneurship literatu...

by Dean Foreman

09/06/1999

Dean Foreman's 28 Laws of Contracting Law #1 - Avoid the Fantasy Land of Wishful Thinking · Law #2 - Use Discovery to Control the Options · Law #3 - The Customer is Not Always Right · Law #4 - Good or Bad, the Customer Is the "Chairman of the Board" · Law #5 - If It Walks Like a Duck and Quacks Like a Duck, It's a Duck · Law #6 - Some Projects Are Better Left to the Next Guy · Law #7 - The Contractor is the "Captain" · Law #8 - Architects are Only Designers · Law #9 - Planning is Not Just Scheduling · Law #10 - Don't "Rig Your Ship" for the Wrong Voyage · Law #11 - Draw a Line in the Sand · Law #12 - Estimating Is Almost as Important as Scheduling · Law #13 - The Pen Is Mightier than the Sword · Law #14 - Use the Contract as a Rifle, Not a Shotgun · Law #15 - If the Contract...

Modern Nature

Essays on Environmental Communication

by Luke Strongman

07/05/2012

This book presents ten essays about environmental communication. Chapter one introduces the concept of environmental communication and the ways in which it was conceived, imagined, and developed as a form of interdisciplinary enquiry. Chapter two explores the concept of green communication and education for the sustainable development movement. Chapter three is concerned with one of the major underlying socio-cultural influences of the human/nature divide: that of anthropomorphic or anthropogenic reasoning. Chapter four takes an ecological view of economics and develops an argument for the place of economic intangibles in the modern political economy. Chapters five and six explore specialist aspects of environmental communication practices: Chapter five is concerned with the contexts of ps...

The Art of Hosting

The Complete Training Guide for Waiters and Restaurant Hosts

by Gerard A. Pollion

07/18/2002

Whether you're new to the business or you've been a server for years, The Art of Hosting will give you the tools you need to walk, talk and act like a seasoned pro.Filled with insider tips and info, this book will show you in clear, concise and easy-to-understand terms how to be an outstanding server in even the finest restaurants-and get the biggest tips!Includes sections on Table Set-up, Taking Guest Orders, Serving Drinks and Wine, Increasing Your Tips and more.

Hidden Treuhand

How Corporations and Individuals Hide Assets and Money

by Shelley A. Stark

07/24/2009

What part is Hidden Treuhand playing in the ensuing global financial crisis? The Hidden Treuhand is the single most powerful business tool in the world of globalization today. It is the missing key, reshaping the world’s financial system though few have ever heard of it. With a Hidden Treuhand you can anonymously exercise complete economic rights in all commercial markets worldwide hiding assets and money from stockholders and taxation alike. Many are unaware that U.S. corporations are using Hidden Treuhand to hide the scope of their economic activities – for example - Halliburton. From banks to bailouts, to shareholder value and pension funds – wealth is disappearing. How is it possible to hide stockholder wealth or economic activities worldwide? Hidden Treuhand is a trade...

by Howard Jackson

02/01/2000

Don't get caught legally unaware-- This book is a must read for real estate appraisers, brokers and attorneys. It explains in a clear way the sometimes difficult but important areas of the law that impact the real estate and legal professions. Some of the main areas covered are how to become an outstanding expert witness, malpractice, ethics, standards of proof, stare decisis, attorney ploys on cross examination, how to become an excellent expert witness, how to bullet proof an appraisal, negligence, common mistakes appraisers make, how to compare two appraisals on the same property. The book is laced with illustrative examples and citations to the court reports. There is also a five page key word index for easy reference. It is organized so that concepts, principles, guidelines, ...

The Fundraising Guide for Chairpersons

Seven Steps to Coordinating Non-Profit and Church Organizations Fund-Raising Events--Including Dinners, Dances, Raffles, Bazaars, Field Days and Lawn Fetes!

by Ron Urbanczyk

07/17/2001

When you run a fund-raising event, there is always a risk that you and your organization could lose rather than make money. In most cases, proper planning and organizing can minimize the risk. In this book, The Chairpersons Guide, Seven Steps to Coordinating Non-Profit and Church Organizations Fund-Raising Events, the author guides the reader through all the critical phases of running a fund-raising event which includes Planning, Organizing, Developing, Marketing, Running, Measuring and Assessing. If you have taken on the challenge and responsibilities of chairing an event, this book is a must read! Developed from over 30 years of personal fund-raising experiences and utilizing common industrial engineering tools used in industry, Ron Urbanczyk guides you through the fundraising pro...

Scientific Approach Principle for New Resilient Coastal Landscape Design

Revitalizing Revere Beach, MA - A Case Study for Flood Mitigation

by Anahita Kianous

06/26/2017

Due to recent climate change, the character of environmental regional planning has shifted to address the anticipated extreme increases in sea level rise. As such, this project, based on existing scientific research/data, proposes a spatial, habitable landscape architectural solution as a model for flood mitigation for the East coastal edge. This proposal tests the potential for resilient coastal landscapes through a particular site located on Revere Beach, along with the New England coast in Massachusetts. The study demonstrates how through new public spaces designed to renew and protect the beach and the broader offshores, residents and visitors will be able to engage with this 21st Century, resilient beachfront. Also, residents and visitors will experience sophisticated efficient flood ...

by Trevor Hicks & Caroline McSherry

02/28/2007

The Health & Safety Executive (HSE) has commissioned recent research which has indicated that: -about half a million people in the UK experience work-related stress at a level they believe is making them ill; -up to 5 million people in the UK feel "very" or "extremely" stressed by their work; and -a total of 12.8 million working days were lost to stress, depression and anxiety in 2004/5. Work-related stress is therefore a serious problem and tackling it effectively can result in significant benefits for organizations. This can result in a happier and more productive workforce with fewer days away from work with stress related illnesses. Managers will also want to comply with recent HSE advice on managing stress within the workplace fulfilling their duty of care to e...

Money: Virtual Energy

Economy through the Prism of Thermodynamics

by Octavian Ksenzhek

07/01/2007

Economic activity of humankind is considered in the book through the prism of fundamental physical concepts of Irreversible Thermodynamics. In the frame of such an approach the Economy appears as an immense global system, which performs work, necessary for functioning human societies, at the expense of dissipation of energy, both biological, provided with food, and technological, used for industrial and everyday needs. Money plays a fundamental role of virtual energy specific for economic processes, that makes possible mutual coupling of energy flows distinct in their nature. The author applies the concept of entropy of money and shows that it depends upon the degree of concentration of money. In turn entropy of money is shown to define attainable level of capability of money to perform wo...

Neighborhood Challenge

The European Union and Its Neighbors

by Birgul Demirtas-Coskun & Bezen Balamir-Coskun

03/24/2009

One of the intriguing questions of the post-Cold War era has been whether the EU will play a major global role in world politics as non-traditional threats and challenges came to the forefront. Launching new policies such as the Common Foreign and Security Policy, the European Security and Defence Policy and the European Neighborhood Policy (ENP) have been considered important steps in the EU?s evolution as a regional and possibly global actor. Neighborhood Challenge analyzes critical aspects of the European Union's relations with its neighbours, by extending its analysis beyond the ENP. Unlike existing books on the subject, the volume covers the entire neighborhood from Russia, Ukraine, and Belarus to North Africa; from the Western Balkans to the South Caucasus and Central Asia. Such an ...

Global Business and Management Research

An International Journal Vol.1, No.1

by Mehran Nejati & Mostafa Nejati (editors)

04/14/2009

The Journal of Global Business and Management Research (GBMR) strives to comply with highest research standards and scientific/research/practice journals' qualities. Being international and inter-disciplinary in scope, GBMR seeks to provide a platform for debate among diverse academic and practitioner communities who address a broad area of business and management issues across the globe.

The Debt Delusion

Evolution and Management of Financial Risk

by Will Slatyer

02/28/2008

In the twenty-first century, corporations delude themselves that their operations are capitalist. In fact the high levels of debt, based on dubious assets reflect "debtism" not "capitalism". Over the ages, debt has crippled countries and economies, companies, large and small, because of biased optimism by lenders and borrowers. Debt is the most common global financial risk and needs to be controlled at Board level, even before trained executives endeavour risk management. The Debt Delusion provides a history of money and debt that should lead all Directors and executives to study recommended ways to manage debt. Management of debt will be extremely important in 2008.

The Temp Factor for Job Seekers

The Job Seeker's Guide to Temporary Employment

by Cathy A. Reilly

08/13/2012

If you are looking for work, consider temporary employment a valuable source of job opportunities. As a temp, you can increase job skills and work experience, expand business networks, strengthen your resume, and avoid gaps in employment, all while being paid. Quite often, temp work can be a “job audition” because it puts temps in front of hiring managers and decision makers for days, weeks, or even months at a time while on job assignments. The Temp Factor for Job Seekers: The Job Seeker's Guide to Temporary Employment presents how this job search strategy may get you back to work faster. Becoming a temp guarantees what a resume cannot: face time inside the doors of potential employers. With over 20 years of experience working with staffing service firms and temps, Cathy A. Reilly ...