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The Approval Process
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Book Synopsis New Drug Approval Process by : Richard A. Guarino
Download or read book New Drug Approval Process written by Richard A. Guarino and published by CRC Press. This book was released on 2004-05-21 with total page 664 pages. Available in PDF, EPUB and Kindle. Book excerpt: Offering expert guidance on the clinical, regulatory, and statistical processes involved in the development of new pharmaceutical product applications for drugs, biologicals, and medical devices, the Fourth Edition details the specific regulations, guidelines, and procedures that will advance and ensure approval of United States and global new product applications. It communicates and integrates a new approach to the world of pharmaceutical personnel on all aspects of new product development and alerts readers to clinical and regulatory tasks that require immediate attention and long-term follow-up in order to comply with the international acceptance of new product approvals.
Book Synopsis Salesforce Advanced Administrator Certification Guide by : Enrico Murru
Download or read book Salesforce Advanced Administrator Certification Guide written by Enrico Murru and published by Packt Publishing Ltd. This book was released on 2019-11-08 with total page 656 pages. Available in PDF, EPUB and Kindle. Book excerpt: Master advanced Salesforce Administration concepts with expert tips, techniques, and mock tests Key FeaturesLearn advanced features to reduce implementation time and enhance your Salesforce administration skillsDevelop the ability to solve critical issues with a proactive approach and deliver the best solutionExplore complex automation with workflows, approvals, process builder, and custom Apex codingBook Description The Salesforce Advanced Administrator certification extends beyond administrator certification, covering advanced platform features and functions such as configuration, automation, security, and customization. Complete with comprehensive coverage of all these topics and exam-oriented questions and mock tests, this Salesforce book will help you earn advanced administrator credentials. You'll start your journey by mastering data access security, monitoring and auditing, and understanding best practices for handling change management and data across organizations. The book then delves into data model management for improving data quality and lets you explore Sales features such as products, schedules, quotes, and forecasting capabilities. As you progress, this book will guide you in working with content management to set up and maintain Salesforce content. You'll also master organizing your files and data using reports and dashboards. Finally, you'll learn how to use a combination of automation tools to solve business problems. By the end of the book, you will have developed the skills required to get your advanced administrator credentials. What you will learnMaster data security to monitor your org effectivelyExplore best practices for handling change management across orgsExtend the capabilities of Salesforce objects using advanced relationships, validation rules, and duplicate managementHandle file libraries with Salesforce CRM contentUnderstand ways to deliver the best solutions with Sales and Service Cloud applicationsBuild reports and dashboards to visualize data for better decision makingCustomize your CRM with process automation featuresWho this book is for If you've already achieved your Salesforce administrator certification, this book will help you prepare for the Salesforce Advanced Administrator certification. You'll also find this guide useful if you are a Salesforce administrator or developer and want to maximize your administration skills with deeper knowledge of advanced Salesforce declarative features. 1-2 years of experience as a Salesforce administrator or developer is enough to help you to get the most out of the book.
Book Synopsis Creating Business Applications with Office 365 by : Jeffrey M. Rhodes
Download or read book Creating Business Applications with Office 365 written by Jeffrey M. Rhodes and published by Apress. This book was released on 2019-11-09 with total page 242 pages. Available in PDF, EPUB and Kindle. Book excerpt: Take your Office 365 and SharePoint projects to a higher level by using PowerApps, Flow, Power BI, JavaScript/jQuery jQuery UI widgets, Cascading Style Sheets (CSS), and more. This book will help you create easier solutions to client-side problems and applications. Additionally, you will be able to effectively visualize your data with Power BI. This book starts with configuration of SharePoint and Office 365 followed by your first example of PowerApps. You will lay the foundation for a help ticket application and see how to update a SharePoint list with PowerApps. You then will work with the jQuery open source library and learn how to use the developer tools within your browser. This allows you to customize data displays in SharePoint. Next, you will add jQuery UI widgets such as buttons and dialogs to SharePoint, learning how to configure and manipulate them via JavaScript. You will use these new skills to convert a normal SharePoint announcement into a visually compelling page of network alerts. You also will use JavaScript and styles to hugely improve native SharePoint calendars by color-coding them by category or location. To prevent overlapping events in calendars, you will work with SharePoint's web services and JavaScript. You will use similar concepts to make appealing accordion SharePoint pages. You then will explore Microsoft Forms, Flow, and Power BI, including building surveys in both Forms and SharePoint and using Power BI to show results over the last week, month, quarter, and year. Using advanced Power BI you will see how to deal with JSON, XML, and Yes/No data. Next, you will look at how to display Office documents as well as interact with them via JavaScript. Switching back to PowerApps, you will build the final help ticketing system before using Power BI to see how to visualize the ticket information. After a quick detour on using iFrames in SharePoint, you will jump into building a power routing application using InfoPath and SharePoint Designer. You will even call SharePoint’s web services from Designer to customize email notifications. You end the InfoPath set of chapters with a highly useful application for signing up for and managing attendance for training and other classes. Finally, you will add Google Analytics to track SharePoint usage. What You Will Learn Build powerful applications with PowerApps Extend SharePoint’s capabilities using JavaScript Create surveys with SharePoint and Microsoft Forms, copy the results to SharePoint using Flow, and visualize the data with Power BIEmploy advanced Power BI techniques to include custom columns, pivoting, and dealing with JSON, XML, and Yes/No dataUse InfoPath and SharePoint workflows to create routing systems, schedule classes, and other advanced tasks Who This Book Is For Business and application developers
Book Synopsis The Use of Drugs in Food Animals by : National Research Council
Download or read book The Use of Drugs in Food Animals written by National Research Council and published by National Academies Press. This book was released on 1999-01-12 with total page 276 pages. Available in PDF, EPUB and Kindle. Book excerpt: The use of drugs in food animal production has resulted in benefits throughout the food industry; however, their use has also raised public health safety concerns. The Use of Drugs in Food Animals provides an overview of why and how drugs are used in the major food-producing animal industriesâ€"poultry, dairy, beef, swine, and aquaculture. The volume discusses the prevalence of human pathogens in foods of animal origin. It also addresses the transfer of resistance in animal microbes to human pathogens and the resulting risk of human disease. The committee offers analysis and insight into these areas: Monitoring of drug residues. The book provides a brief overview of how the FDA and USDA monitor drug residues in foods of animal origin and describes quality assurance programs initiated by the poultry, dairy, beef, and swine industries. Antibiotic resistance. The committee reports what is known about this controversial problem and its potential effect on human health. The volume also looks at how drug use may be minimized with new approaches in genetics, nutrition, and animal management.
Book Synopsis New Drugs by : Lawrence Tim Friedhoff
Download or read book New Drugs written by Lawrence Tim Friedhoff and published by Booksurge Publishing. This book was released on 2009 with total page 0 pages. Available in PDF, EPUB and Kindle. Book excerpt: Drug development, the processes by which a chemical compound becomes a "drug" and is approved for sale by the FDA and European and Asian regulators, is not for the faint-of-heart or the shortsighted. Designing and monitoring studies, obtaining and analyzing scientific data, and reconciling clinical results against the ethical constraints and regulatory guidelines of government agencies, requires a complex interaction of in-house specialists and academic and commercial consultants worldwide. Scientific, technical, and tactical considerations play out in an environment where a balance must be struck between the often-competing interests of the corporation, its investors, government regulators, and the safety and well being of intended patients. All the while, dwindling patent protections impose an ever-contracting timeframe for success. Written to be accessible to a wide audience, NEW DRUGS provides a thorough, succinct, and practical understanding of these drug-development processes. If you're involved in the pharmaceutical industry, NEW DRUGS will provide scientific and management tools to increase the likelihood of regulatory approval at each phase of your compound's development. If you're a patient or consumer, NEW DRUGS will enable you to intelligently discuss medications with your health-care provider and empower you to make informed decisions at the pharmacy. If your portfolio, rather than your health, makes you an interested observer of the fortunes of this critical sector of the US economy, NEW DRUGS will help you to decode press releases and annual reports, so that you can recognize and invest in well-run companies with promising products.
Book Synopsis Enhancing the Regulatory Decision-Making Approval Process for Direct Food Ingredient Technologies by : Institute of Medicine
Download or read book Enhancing the Regulatory Decision-Making Approval Process for Direct Food Ingredient Technologies written by Institute of Medicine and published by National Academies Press. This book was released on 1999-04-29 with total page 158 pages. Available in PDF, EPUB and Kindle. Book excerpt: The Institute of Medicine's (IOM's) Food Forum was established in 1993 to allow science and technology leaders in the food industry, top administrators in the federal government, representatives from consumer interest groups, and academicians to discuss and debate food and food safety issues openly and in a neutral setting. The Forum provides a mechanism for these diverse groups to identify possible approaches for addressing food and food safety problems and issues surrounding the often complex interactions among industry, academia, regulatory agencies, and consumers. On May 6-7, 1997, the Forum convened a workshop titled Enhancing the Regulatory Decision-Making Process for Direct Food Ingredient Technologies. Workshop speakers and participants discussed legal aspects of the direct food additive approval process, changes in science and technology, and opportunities for reform. Two background papers, which can be found in Appendix A and B, were shared with the participants prior to the workshop. The first paper provided a description and history of the legal framework of the food ingredient approval process and the second paper focused on changes in science and technology practices with emphasis placed on lessons learned from case studies. This document presents a summary of the workshop.
Book Synopsis The Salesforce Career Playbook by : Martin Gessner
Download or read book The Salesforce Career Playbook written by Martin Gessner and published by . This book was released on 2020-10-29 with total page 424 pages. Available in PDF, EPUB and Kindle. Book excerpt: "This book is the missing link ... and should be required reading for anyone looking to launch or grow a career within the Salesforce ecosystem." -Selina Suarez, Executive director/founder, PepUp Tech In the next two years, an estimated 3.3 million jobs in the Salesforce ecosystem will open, and one of them could be yours. But how can you sort through all these jobs-administrators, architects, analysts, developers, consultants-and find the one that is right for you? And how do you package yourself to win the job position?Martin Gessner, author of The Salesforce Career Playbook, is known in the Salesforce community for his highly regarded Salesforce credentials training. He has helped thousands of Salesforce professionals learn Salesforce, develop their careers, and prepare for certifications.Now, he has written the definitive guide to starting your Salesforce career, and moving up the ladder. From the Back Cover Packed with case studies and advice from people in the trenches of a Salesforce career, The Salesforce Career Playbook will help you: Find job opportunities and showcase your skills so that you land a job...and not just any old job, but the right job that is best suited to your personality, skills, and lifestyle preferences. Sort through the different careers available, and see a day-in-the-life of real Salesforce professionals working in these jobs.Learn insider tips and strategies for developing and growing your career once you have joined the Salesforce ecosystem.Regardless of whether you have a master's degree in information technology or no formal education beyond eighth grade, you can earn a more-than-competitive wage and move up the ladder in a Salesforce-related career, and jobs are available for techies and not-techies alike. Editorial Reviews "I wish I had read The Salesforce Career Playbook six years ago when I did my transition into the Salesforce ecosystem."-Sergey Erlikh, MVP and solution architect "People don't put in enough time thinking about their careers. You can't just work hard and hope everything works out okay. You have to proactively plan your short- and long-term career, which is why I recommend studying Martin's Salesforce Career Playbook!"-David Liu, Salesforce technical architect, Salesforce MVP "I love the advice from all the people already working in Salesforce, from the nuts and bolts of landing the first job to the high-level advice for finding the right trajectory."-Christine Marshall, MVP and Salesforce administrator"Whether you are a newbie, a career-changer, or advancing in your career, this book will help you find and take the next step."-Ben Duncombe, Director and Salesforce recruitment specialist at Talent Hub, a Salesforce recruitment firm "There's much more to being a successful Salesforce professional than simply accumulating Trailhead badges and Salesforce certifications. This book sheds light on some of the other critical elements (and skills) needed for career success."-David Giller, Salesforce Consultant & Trainer, CEO at Brainiate" This book is about finding your home in Salesforce-and not just any home, but the right home. It's about figuring out who you are as a person and making sure you align your career with what you want out of life." -Anna Loughnan, CRM product lead, community group leader, Salesforce MVP "An excellent read for those navigating their Salesforce careers! Packed with tips for positioning yourself and getting hired." -Stuart Smith, Co-founder and director of SaaSpeople, a Salesforce recruitment firm "This book should be required reading for anyone interested in starting or advancing their career in Salesforce." -Vickie Jeffery, Salesforce MVP, technology manager, Ausure, one of Australia's largest insurance broking companies
Book Synopsis Approved Prescription Drug Products by :
Download or read book Approved Prescription Drug Products written by and published by . This book was released on 1981 with total page 16 pages. Available in PDF, EPUB and Kindle. Book excerpt: Accompanied by supplements.
Book Synopsis Practical Salesforce Development Without Code by : Philip Weinmeister
Download or read book Practical Salesforce Development Without Code written by Philip Weinmeister and published by Apress. This book was released on 2019-06-04 with total page 532 pages. Available in PDF, EPUB and Kindle. Book excerpt: Use this hands-on guide to build powerful solutions on the Salesforce platform without using a single line of code. This revised and expanded second edition includes Process Builder, Flow Builder, Lightning App Builder, Lightning Bolt Solutions, and more. Practical Salesforce Development Without Code shows you how to unlock the power of the Salesforce platform to solve real business problems. Adhering to Salesforce's "clicks, not code" mantra, Salesforce expert Phil Weinmeister walks Salesforce newcomers and veterans through different business problems and identifies effective—and proven—approaches to solutions using the platform's declarative framework. By adopting this book as your guide, you will learn how to deliver business solutions within Salesforce by combining analysis, creativity, and logic with core elements such as validation rules, workflow rules, processes, flows, formula fields, and Lightning apps. In addition, Weinmeister dissects and explains the most useful functions and features for declarative developers and shows you how to use them. Best of all, Weinmeister uses real-life business scenarios and visuals. Applying the lessons learned from this how-to guide will ultimately save you time and ensure that your clients or internal customers are enabled, equipped, and empowered. What You'll Learn Build objects, fields, and relationships to establish a sensible data model Automate business processes by using Workflow, Process Builder, and Flow Utilize functions and develop formulas effectively for a variety of business needs Develop approval processes to handle exception scenarios Employ actions to easily create efficient and relevant user experiences Manage your environments and deploy your solutions Who This Book Is for Business analysts, Salesforce administrators, and Salesforce developers
Book Synopsis Strong Towns by : Charles L. Marohn, Jr.
Download or read book Strong Towns written by Charles L. Marohn, Jr. and published by John Wiley & Sons. This book was released on 2019-10-01 with total page 262 pages. Available in PDF, EPUB and Kindle. Book excerpt: A new way forward for sustainable quality of life in cities of all sizes Strong Towns: A Bottom-Up Revolution to Build American Prosperity is a book of forward-thinking ideas that breaks with modern wisdom to present a new vision of urban development in the United States. Presenting the foundational ideas of the Strong Towns movement he co-founded, Charles Marohn explains why cities of all sizes continue to struggle to meet their basic needs, and reveals the new paradigm that can solve this longstanding problem. Inside, you’ll learn why inducing growth and development has been the conventional response to urban financial struggles—and why it just doesn’t work. New development and high-risk investing don’t generate enough wealth to support itself, and cities continue to struggle. Read this book to find out how cities large and small can focus on bottom-up investments to minimize risk and maximize their ability to strengthen the community financially and improve citizens’ quality of life. Develop in-depth knowledge of the underlying logic behind the “traditional” search for never-ending urban growth Learn practical solutions for ameliorating financial struggles through low-risk investment and a grassroots focus Gain insights and tools that can stop the vicious cycle of budget shortfalls and unexpected downturns Become a part of the Strong Towns revolution by shifting the focus away from top-down growth toward rebuilding American prosperity Strong Towns acknowledges that there is a problem with the American approach to growth and shows community leaders a new way forward. The Strong Towns response is a revolution in how we assemble the places we live.
Book Synopsis How the Trading Floor Really Works by : Terri Duhon
Download or read book How the Trading Floor Really Works written by Terri Duhon and published by John Wiley & Sons. This book was released on 2012-08-23 with total page 372 pages. Available in PDF, EPUB and Kindle. Book excerpt: A detailed look at what really happens in the front office of an investment bank and why Trading floors have always fascinated people, but few understand the role they play in the world of finance today. Though markets rise and fall every day, the drivers of those are rarely explored. Those who understand the dynamics of trading floors will better understand the dynamics of global financial markets. This book reveals the key players on the floor, their roles and responsibilities, how they serve their clients, and how it all impacts the markets. It also explains important terminology, explains the world of trading both cash and derivatives, and much more. Includes a foreword by Gillian Tett, author of Fool's Gold: How Unrestrained Greed Corrupted a Dream, Shattered Global Markets and Unleashed a Catastrophe. Terri Duhon (www.terriduhon.co) is a financial market expert who in 2004 founded B&B Structured Finance Ltd, which provides expert consulting and financial markets training . Her time on the trading floor has been documented in the book Fool's Gold as well as by PBS's Frontline.
Download or read book Epilepsy written by Gregory D. Cascino and published by John Wiley & Sons. This book was released on 2021-02-22 with total page 648 pages. Available in PDF, EPUB and Kindle. Book excerpt: Designed to provide a comprehensive but accessible introduction to epilepsy and seizure disorders, Epilepsy, 2nd edition provides state-of-the-art information in a concise format useful to a wide audience, from neurology residents to epilepsy fellows and practitioners. This illustrated guide to the assessment, diagnosis, and treatment of epilepsy is a valuable resource enabling clinicians to stay on top of the latest recommendations for best practice.
Author :National Academies of Sciences, Engineering, and Medicine Publisher :National Academies Press ISBN 13 :0309459575 Total Pages :483 pages Book Rating :4.3/5 (94 download)
Book Synopsis Pain Management and the Opioid Epidemic by : National Academies of Sciences, Engineering, and Medicine
Download or read book Pain Management and the Opioid Epidemic written by National Academies of Sciences, Engineering, and Medicine and published by National Academies Press. This book was released on 2017-09-28 with total page 483 pages. Available in PDF, EPUB and Kindle. Book excerpt: Drug overdose, driven largely by overdose related to the use of opioids, is now the leading cause of unintentional injury death in the United States. The ongoing opioid crisis lies at the intersection of two public health challenges: reducing the burden of suffering from pain and containing the rising toll of the harms that can arise from the use of opioid medications. Chronic pain and opioid use disorder both represent complex human conditions affecting millions of Americans and causing untold disability and loss of function. In the context of the growing opioid problem, the U.S. Food and Drug Administration (FDA) launched an Opioids Action Plan in early 2016. As part of this plan, the FDA asked the National Academies of Sciences, Engineering, and Medicine to convene a committee to update the state of the science on pain research, care, and education and to identify actions the FDA and others can take to respond to the opioid epidemic, with a particular focus on informing FDA's development of a formal method for incorporating individual and societal considerations into its risk-benefit framework for opioid approval and monitoring.
Book Synopsis Analysis of the Education Program Approval Process by : Charles Fountaine
Download or read book Analysis of the Education Program Approval Process written by Charles Fountaine and published by . This book was released on 1988 with total page 138 pages. Available in PDF, EPUB and Kindle. Book excerpt:
Book Synopsis Medical Devices and the Public's Health by : Institute of Medicine
Download or read book Medical Devices and the Public's Health written by Institute of Medicine and published by National Academies Press. This book was released on 2011-11-25 with total page 318 pages. Available in PDF, EPUB and Kindle. Book excerpt: Medical devices that are deemed to have a moderate risk to patients generally cannot go on the market until they are cleared through the FDA 510(k) process. In recent years, individuals and organizations have expressed concern that the 510(k) process is neither making safe and effective devices available to patients nor promoting innovation in the medical-device industry. Several high-profile mass-media reports and consumer-protection groups have profiled recognized or potential problems with medical devices cleared through the 510(k) clearance process. The medical-device industry and some patients have asserted that the process has become too burdensome and is delaying or stalling the entry of important new medical devices to the market. At the request of the FDA, the Institute of Medicine (IOM) examined the 510(k) process. Medical Devices and the Public's Health examines the current 510(k) clearance process and whether it optimally protects patients and promotes innovation in support of public health. It also identifies legislative, regulatory, or administrative changes that will achieve the goals of the 510(k) clearance process. Medical Devices and the Public's Health recommends that the U.S. Food and Drug Administration gather the information needed to develop a new regulatory framework to replace the 35-year-old 510(k) clearance process for medical devices. According to the report, the FDA's finite resources are best invested in developing an integrated premarket and postmarket regulatory framework.
Download or read book Drugs written by Rick Ng and published by John Wiley & Sons. This book was released on 2011-09-20 with total page 368 pages. Available in PDF, EPUB and Kindle. Book excerpt: "Concise and easy to read, the book quickly introduces basic concepts, then moves on to discuss target selection and the drug discovery process for both small and large molecular drugs." —Doody's Reviews, May 2009 "The second edition of a book that offers a user-friendly step-by-step introduction to all the key processes involved in bringing a drug to the market, including the performance of preclinical trials." —Chemistry World, February 2009 The new edition of this best-selling book continues to offer a user-friendly, step-by-step introduction to all the key processes involved in bringing a drug to the market, including the performance of pre-clinical studies, the conduct of human clinical trials, regulatory controls, and even the manufacturing processes for pharmaceutical products. Concise and easy to read, the book quickly introduces basic concepts, then moves on to discuss target selection and the drug discovery process for both small and large molecular drugs. This second edition features many key enhancements, including Key Points, Chapter Summary, and Review Questions in each chapter, Answers to Review Questions provided in a book-end appendix, and one or two carefully selected "mini" case studies in each chapter. Richly illustrated throughout with over ninety figures and tables, this important book also includes helpful listings of current FDA and European guidelines and a special section on regulatory authority and processes in China. It is an indispensable resource for pharmaceutical industry and academic researchers, pharmaceutical managers and executives, healthcare clinicians, policymakers, regulators, and lobbyists with an interest in drug development. It is also an excellent textbook for students in pharmacy, science, and medicine courses.
Book Synopsis Robert's Rules of Order Newly Revised, 12th edition by : Henry M. Robert III
Download or read book Robert's Rules of Order Newly Revised, 12th edition written by Henry M. Robert III and published by PublicAffairs. This book was released on 2020-08-25 with total page 848 pages. Available in PDF, EPUB and Kindle. Book excerpt: The only current authorized edition of the classic work on parliamentary procedure--now in a new updated edition Robert's Rules of Order is the recognized guide to smooth, orderly, and fairly conducted meetings. This 12th edition is the only current manual to have been maintained and updated since 1876 under the continuing program established by General Henry M. Robert himself. As indispensable now as the original edition was more than a century ago, Robert's Rules of Order Newly Revised is the acknowledged "gold standard" for meeting rules. New and enhanced features of this edition include: Section-based paragraph numbering to facilitate cross-references and e-book compatibility Expanded appendix of charts, tables, and lists Helpful summary explanations about postponing a motion, reconsidering a vote, making and enforcing points of order and appeals, and newly expanded procedures for filling blanks New provisions regarding debate on nominations, reopening nominations, and completing an election after its scheduled time Dozens more clarifications, additions, and refinements to improve the presentation of existing rules, incorporate new interpretations, and address common inquiries Coinciding with publication of the 12th edition, the authors of this manual have once again published an updated (3rd) edition of Robert's Rules of Order Newly Revised In Brief, a simple and concise introductory guide cross-referenced to it.
