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Regulatory Affairs in the Pharmaceutical Industry is a comprehensive reference that compiles all the information available pertaining to regulatory procedures currently followed by the pharmaceutical industry. Designed to impart advanced knowledge and skills required to learn the various concepts of regulatory affairs, the content covers new drugs, generic drugs and their development, regulatory filings in different countries, different phases of clinical trials, and the submission of regulatory documents like IND (Investigational New Drug), NDA (New Drug Application) and ANDA (Abbreviated New Drug Application). Chapters cover documentation in the pharmaceutical industry, generic drug development, code of Federal Regulation (CFR), the ANDA regulatory approval process, the process and documentation for US registration of foreign drugs, the regulation of combination products and medical devices, the CTD and ECTD formats, and much more.

European Glacial Landscapes: Maximum Extent of Glaciations brings together relevant experts on the history of glaciers and their impact on the landscape of the main regions of Europe. In some regions the largest recorded glaciations occurred before the Last Glacial Cycle, in one of the major glacial cycles of the Middle Pleistocene. However, the best-preserved evidence of glaciation in the landscape is from the Last Glacial Cycle (Late Pleistocene). The book also analyses these older glacial landforms that can sometimes still be seen in the landscape today. This analysis provides a better understanding of the succession of Pleistocene glaciations and the intervening interglacial periods, examining their possible continental synchrony or asynchrony of past glacier behaviour. The result of this analysis gives important new insights and information on the origin and effects of climatic and geomorphological variability across Europe. European Glacial Landscapes: Maximum Extent of Glaciations examines the landscapes produced by glaciers throughout Europe, the geomorphological effects of glaciations, as well as the chronology and evolution of the past glaciers, with the aim of understanding the interrelationship between glacial expansion and climate changes on this continent. This book is a valuable tool for geographers, geologist, environmental scientists, researchers in physics and earth sciences.

Resources designed to support learners of the new next generation BTEC First in Travel & Tourism specification*. Covers all core and mandatory units and a wide selection of optional units. (Units 1-10 in the Student Book and Units 11-13 on the Pearson website.) Each unit of the Student Book is presented in topics to ensure the content is accessible and engaging for learners. Covers of all the underpinning knowledge and understanding needed at level 2 to ensure that learners are fully prepared for this course. Activities in each unit provide support and clear direction for learners and can be used in the classroom or for independent work. New Assessment Zone guides learners through both internal and external assessment. Practice assignments and assessment guidance help learners to achieve their potential in internally assessed units. We can confirm that Units 11-13 are now available online to everyone who purchases the Student Book. * From 2012, Pearson's BTEC First qualifications have been under re-development, so schools and colleges could be teaching the existing 2010 specification or the new next generation 2012-2013 specification. There are different Student Books to support each specification. If learners are unsure, they should check with their teacher or tutor.

Value-Chain of Biofuels: Fundamentals, Technology, and Standardization presents the fundamental aspects of biofuel production, from biomass conversion technologies and biofuels' end products to related policy regulation and standardization. Sections explore the current biofuels industry, addressing pretreatment, feedstocks, and conversion processes, review different pathways to produce biofuels, including bioethanol, biochar, biogas/bio-hydrogen, bio-oil, biodiesel, and many others, and finally, present policy regulation and standardization on biofuel production, with a focus on applications. Case studies are provided alongside reviews from academic and industry perspectives, discussing economics and lifecycle assessments (LCA) of biofuel production, as well as analyses of supply chains. Offering a comprehensive and timely overview, this book provides an ideal reference for researchers and practitioners working in bioenergy and renewable energy, but it will also be of interest to chemists, bioengineers, chemical engineers, and the agricultural and petrochemical industries.

Uranium Geology of the Middle East and North Africa demonstrates mining potential in the MENA region, with a special interest given to Uranium. The formation and origin of uranium deposits is of interest for uranium exploration and is necessary for the long-term sustainability of nuclear energy production. The book proposes a new classification system built on earlier classification with detailed new maps, explanatory diagrams, cross sections, helpful satellite images, etc. In addition, it explains why the occurrences, depositional and geological environments of uranium in the Middle East and North Africa vary from one country to another. Using various related recognition criteria, the book reports the potential uranium provinces in the Middle East and North Africa countries. The definition of these provinces is based on the existing geologic and tectonic settings, along with geochronological sequences and geochemical characteristics.

Now in its second edition, this updated text explores the contemporary trends in retail and channel marketing. Disentangling the complexity of channel marketing issues, it offers a systematic overview of the key concepts and intricacies of the subject and provides a holistic approach to retail and channel marketing.   Key features of the second edition include: Coverage of both the core tenets and the latest research frontiers in the field A new chapter detailing the history of retailing and its importance to modern economies Updated case examples based on real-world scenarios to reinforce understanding of complex topics Exploration of key concerns of commercial sector analysis and retail marketing through the lenses of the manufacturer, the retailer and the customer. Offering a comprehensive introduction to both foundational topics and advanced concepts, this textbook is ideal for courses relating to channel marketing and retail management, as well as MBA courses on marketing and go-to-market strategy.

Tourism destinations are traditionally dominated by small and medium-sized enterprises that provide a wide range of products to tourists such as accommodation, travel services, transportation, recreation and entertainment, and food and beverage services. New knowledge and global risks have emerged, and small and medium-sized tourism enterprises (SMTEs) are now highly vulnerable. Recently, the COVID-19 pandemic has hit the whole world and caused a change in the tourism paradigm. Many SMTEs around the world have been severely affected by the need to completely shut down their activities for months, and expectations for recovery in the medium term are not optimistic. SMTEs do not have the capacity and increased resources-financial, human, operational-of large companies to prepare for crisis contingencies (planning) and respond to the challenges they face. They simply do not have the resources or knowledge for risk analysis and the creation of crisis teams or plans. This is an area of growing importance and concern, both in the public and private sectors, where specific research and more in-depth knowledge are needed. Risk, Crisis, and Disaster Management in Small and Medium-Sized Tourism Enterprises connects research in the field of crisis management with the risks affecting small and medium-sized tourism enterprises. The book presents prevailing research on SME-related planning, response, and recovery during crisis situations, further propelling much-needed literature on these challenges in today's tourism industry. The chapters cover important topics such as terrorism threats, disaster management, resilient strategies, pandemic management, and risk analysis. The target audience of this book will be composed of professionals working in the tourism and hospitality industries, restaurateurs, travel agencies, hotel executives, directors, managers, crisis and risk planners, policymakers, government officials, researchers, and academicians who are interested in the threats to tourism businesses and how small and medium-sized enterprises can manage and navigate these risks.

We are at a defining point in the history of news. Following a surge of fake news, clickbait and conspiracy theories, the 2020s have ushered in a welter of existential threats for public service broadcasting. So, where do we go from here? Former Today editor and head of BBC television news Roger Mosey thinks public service broadcasters must buck the trends and in this incisive book he offers twenty core ways in which the news can save itself by getting smarter, sharper, more diverse, more nuanced and less exposed to pummelling by politicians. Mosey sees two possible futures: one in which the incitements of populist demagogues and the passions of social media are ever dominant - or one where we fight hard to retain media that has an interest in the public good and preserves truth, fairness and evidence-based judgements. From one of British broadcasting's most experienced voices comes the definitive exploration of Britain's news output and what must change if we are to avoid a future of uninspiring news, uninformed decision-making and accountability-dodging politicians.

The Oceanography of the Eastern English Channel: Past, Present and Future, Volume 90 in the Advances in Marine Biology series, is the latest release in a series that has been providing in-depth and up-to-date reviews on all aspects of marine biology since 1963. Readers will find updates on many topics that will appeal to postgraduates and researchers in marine biology, fisheries science, ecology, zoology and biological oceanography. Chapters in this new release include Marine Environmental DNA: Approaches, Applications, and Opportunities, and The Biology and Ecology of the Banana Prawns.

Fundamental Issues Critical to the Success of Nuclear Projects presents a complete analysis of the core considerations for those deploying nuclear power plants, managing existing plants, and also for those developing and building new plants. It includes critical considerations, such as cost-estimation, safety procedures, and regulatory compliance, manpower optimization and development, and the application of innovative technologies, such as the use of robotics. Those important issues have been addressed in a systematic way, and explanations have been provided on how the nuclear industry has continuously found solutions to mitigate and eventually solve them properly.

In a globalized world full of noise, brands are constantly launching messages through different channels. For the last two decades, brands, marketers, and creatives have faced the difficult task of reaching those individuals who do not want to watch or listen to what they are trying to tell them. By producing fewer ads or making them louder or more striking, more brands and communications professionals are not going to get those people to pay more attention to their messages; they will only want to avoid advertising in all media. Examining the Future of Advertising and Brands in the New Entertainment Landscape provides a theoretical, reflective, and empirical perspective on branded content and branded entertainment in relation to audience engagement. It reviews different cases about branded content to address the dramatic change that brands and conventional advertising are facing short term. Covering topics such as branded content measurement tools, digital entertainment culture, and government storytelling, this premier reference source is an excellent resource for marketers, advertising agencies, brand managers, business leaders and managers, communications professionals, government officials, non-profit organizations, students and educators of higher education, academic libraries, researchers, and academicians.