Download or read book Regulatory Intelligence 101 Third Edition written by Gloria Hall and published by . This book was released on 2021-03-26 with total page pages. Available in PDF, EPUB and Kindle. Book excerpt:
Download or read book Regulatory Intelligence 101 written by Meredith Brown-Tuttle and published by . This book was released on 2016 with total page 150 pages. Available in PDF, EPUB and Kindle. Book excerpt:
Download or read book Regulatory Intelligence 101 written by Meredith Brown-Tuttle and published by . This book was released on 2014-08-04 with total page pages. Available in PDF, EPUB and Kindle. Book excerpt: Guide to how to conduct regulatory intelligence, available tools and resources.
Download or read book FDA Regulatory Affairs written by David Mantus and published by CRC Press. This book was released on 2014-02-28 with total page 402 pages. Available in PDF, EPUB and Kindle. Book excerpt: FDA Regulatory Affairs is a roadmap to prescription drug, biologics, and medical device development in the United States. Written in plain English, the concise and jargon-free text demystifies the inner workings of the US Food and Drug Administration (FDA) and facilitates an understanding of how the agency operates with respect to compliance and product approval, including clinical trial exemptions, fast track status, advisory committee procedures, and more. The Third Edition of this highly successful publication: Examines the harmonization of the US Federal Food, Drug, and Cosmetic Act with international regulations on human drug, biologics and device development, research, manufacturing, and marketing Includes contributions from experts at organizations such as the FDA, National Institutes of Health (NIH), and PAREXEL Focuses on the new drug application (NDA) process, cGMPs, GCPs, quality system compliance, and corresponding documentation requirements Provides updates to the FDA Safety and Innovation Act (FDASIA), incorporating pediatric guidelines and follow-on biologics regulations from the 2012 Prescription Drug User Fee Act (PDUFA) V Explains current FDA inspection processes, enforcement options, and how to handle FDA meetings and required submissions Co-edited by an industry leader (Mantus) and a respected academic (Pisano), FDA Regulatory Affairs, Third Edition delivers a compilation of the selected US laws and regulations as well as a straightforward commentary on the FDA product approval process that’s broadly useful to both business and academia.
Download or read book FDA Regulatory Affairs written by Douglas J. Pisano and published by CRC Press. This book was released on 2008-08-11 with total page 466 pages. Available in PDF, EPUB and Kindle. Book excerpt: Examines harmonization of the US Federal Food, Drug, and Cosmetic Act with international regulations as they apply to human drug and device development, research, manufacturing, and marketing. The Second Edition focuses on the new drug approval process, cGMPs, GCPs, quality system compliance, and corresponding documentation requirements. Written in
Download or read book Strategies for Regulatory Intelligence written by Chris Walker and published by . This book was released on 2001 with total page pages. Available in PDF, EPUB and Kindle. Book excerpt:
Download or read book Contemporary Regulatory Policy written by Marc Allen Eisner and published by . This book was released on 2018 with total page 359 pages. Available in PDF, EPUB and Kindle. Book excerpt: "The third edition of [this book reflects] more than a decade of policy changes and including an entirely new chapter on food safety regulation. Beyond their focus on seven key policy arenas, the authors confront the broad problems of partisan polarization and congressional gridlock. They also consider the significance of unilateral policy actions by President Obama and how these initiatives may be vulnerable to change under President Trump. Recognizing that no single theory can sufficiently explain regulatory politics, they offer a comprehensive set of tools for understanding the world of regulatory policy today."--
Download or read book Global Regulatory Information Management Third Edition written by Gerardus Blokdyk and published by . This book was released on 2018 with total page 0 pages. Available in PDF, EPUB and Kindle. Book excerpt: Global Regulatory Information Management Third Edition.
Download or read book Regulatory Intelligence in Small Companies written by Kevin Lane Hollister and published by . This book was released on 2008 with total page 146 pages. Available in PDF, EPUB and Kindle. Book excerpt:
Download or read book Drug Discovery and Development Third Edition written by James J. O'Donnell and published by CRC Press. This book was released on 2019-11-21 with total page 697 pages. Available in PDF, EPUB and Kindle. Book excerpt: Drug Discovery and Development, Third Edition presents up-to-date scientific information for maximizing the ability of a multidisciplinary research team to discover and bring new drugs to the marketplace. It explores many scientific advances in new drug discovery and development for areas such as screening technologies, biotechnology approaches, and evaluation of efficacy and safety of drug candidates through preclinical testing. This book also greatly expands the focus on the clinical pharmacology, regulatory, and business aspects of bringing new drugs to the market and offers coverage of essential topics for companies involved in drug development. Historical perspectives and predicted trends are also provided. Features: Highlights emerging scientific fields relevant to drug discovery such as the microbiome, nanotechnology, and cancer immunotherapy; and novel research tools such as CRISPR and DNA-encoded libraries Case study detailing the discovery of the anti-cancer drug, lorlatinib Venture capitalist commentary on trends and best practices in drug discovery and development Comprehensive review of regulations and their impact on drug development, highlighting special populations, orphan drugs, and pharmaceutical compounding Multidiscipline functioning of an Academic Research Enterprise, plus a chapter on Ethical Concerns in Research Contributions by 70+ experts from industry and academia specialists who developed and are practitioners of the science and business
Download or read book Intelligence Community Legal Reference Book written by and published by . This book was released on 2012 with total page 944 pages. Available in PDF, EPUB and Kindle. Book excerpt:
Download or read book Responsive Regulation written by Ian Ayres and published by Oxford University Press. This book was released on 1995-02-16 with total page 216 pages. Available in PDF, EPUB and Kindle. Book excerpt: This book transcends current debate on government regulation by lucidly outlining how regulations can be a fruitful combination of persuasion and sanctions. The regulation of business by the United States government is often ineffective despite being more adversarial in tone than in other nations. The authors draw on both empirical studies of regulation from around the world and modern game theory to illustrate innovative solutions to this problem. Their ideas include an argument for the empowerment of private and public interest groups in the regulatory process and a provocative discussion of how the government can support and encourage industry self-regulation.
Download or read book Global Trends 2040 written by National Intelligence Council and published by Cosimo Reports. This book was released on 2021-03 with total page 158 pages. Available in PDF, EPUB and Kindle. Book excerpt: "The ongoing COVID-19 pandemic marks the most significant, singular global disruption since World War II, with health, economic, political, and security implications that will ripple for years to come." -Global Trends 2040 (2021) Global Trends 2040-A More Contested World (2021), released by the US National Intelligence Council, is the latest report in its series of reports starting in 1997 about megatrends and the world's future. This report, strongly influenced by the COVID-19 pandemic, paints a bleak picture of the future and describes a contested, fragmented and turbulent world. It specifically discusses the four main trends that will shape tomorrow's world: - Demographics-by 2040, 1.4 billion people will be added mostly in Africa and South Asia. - Economics-increased government debt and concentrated economic power will escalate problems for the poor and middleclass. - Climate-a hotter world will increase water, food, and health insecurity. - Technology-the emergence of new technologies could both solve and cause problems for human life. Students of trends, policymakers, entrepreneurs, academics, journalists and anyone eager for a glimpse into the next decades, will find this report, with colored graphs, essential reading.
Download or read book InsurTech A Legal and Regulatory View written by Pierpaolo Marano and published by Springer Nature. This book was released on 2019-12-05 with total page 396 pages. Available in PDF, EPUB and Kindle. Book excerpt: This Volume of the AIDA Europe Research Series on Insurance Law and Regulation explores the key trends in InsurTech and the potential legal and regulatory issues that accompany them. There is a proliferation of ideas and concepts within InsurTech that will fundamentally change the market in the next few years. These innovations have the potential to change the way the insurance industry works and alter the relationships between customers and insurers, resulting in insurance products that are more closely aligned to individual preferences and priced more appropriately to the risk. Increasing use of technology in the insurance sector is having both a disruptive and transformative impact on areas including product development, distribution, modelling, underwriting and claims and administration practice. The result is a new industry, known as InsurTech. But while the insurance market looks to technology for greater efficiency, regulators are beginning to raise concerns about managing potential risks. The first part of the book examines technological innovations relevant for insurance, such as FinTech, InsurTech, Sharing Economy, and the Internet of Things. The second part then gathers contributions on insurance contract law in a digitalized world, while the third part focuses on cyber insurance and robots. Last but not least, the fourth part of the book discusses legal and ethical questions regarding autonomous vehicles and transportation, including the shipping industry, as well as their impact on the insurance sector and civil liability. Written by legal scholars and practitioners, the book offers international, comparative and European perspectives. The Chapters "FinTech, InsurTech and the Regulators" by Viktoria Chatzara, "Smart Contracts in Insurance. A Law and Futurology Perspective" by Angelo Borselli and "Room for Compulsory Product Liability Insurance in the European Union for Smart Robots?” by Aysegul Bugra are available open access under a CC BY 4.0 license at link.springer.com. All three open access chapters were funded by BIPAR.
Download or read book Global Business Regulation written by John Braithwaite and published by Cambridge University Press. This book was released on 2000-02-13 with total page 194 pages. Available in PDF, EPUB and Kindle. Book excerpt: How has the regulation of business shifted from national to global institutions? What are the mechanisms of globalization? Who are the key actors? What of democratic sovereignty? In which cases has globalization been successfully resisted? These questions are confronted across an amazing sweep of the critical areas of business regulation--from contract, intellectual property and corporations law, to trade, telecommunications, labor standards, drugs, food, transport and environment. This book examines the role played by global institutions such as the World Trade Organization, World Health Organization, the OECD, IMF, Moodys and the World Bank, as well as various NGOs and significant individuals. Incorporating both history and analysis, Global Business Regulation will become the standard reference for readers in business, law, politics, and international relations.
Download or read book Homeland Security A Complete Guide 3E written by Mark Sauter and published by McGraw Hill Professional. This book was released on 2019-04-12 with total page 704 pages. Available in PDF, EPUB and Kindle. Book excerpt: Publisher's Note: Products purchased from Third Party sellers are not guaranteed by the publisher for quality, authenticity, or access to any online entitlements included with the product. The definitive guide to the homeland security enterprise―updated with critical changes in missions, tactics, and strategies International terrorists and rogue nations continue to threaten U.S. citizens, while domestic extremist groups seek to attack the American way of life and hackers take advantage of the Internet to inflict new types of havoc at work and home. Meanwhile, today’s human-made and natural disasters can impact communities on the scale of weapons of mass destruction. Given the range and intensity of today’s threats, we’re all on the front lines of national security. The most detailed and comprehensive work of its kind, Homeland Security: A Complete Guide provides insights to keep yourself, your family, your business, and your community safe from terrorism and disaster. Written by two global experts on domestic security, this new edition brings you up to date on the latest threats to U.S. security and the most effective methods for eliminating or mitigating them. Homeland Security: A Complete Guide, Third Edition has been expanded and revised to include: NEW insights on cyber security, Electro-Magnetic Pulse, and other emerging threatsNEW techniques and controversies, such metadata collection, surveillance by US intelligence agencies, drones, interrogation, and countering violent extremist programsNEW information about homegrown terrorism and radicalization NEW content about ISIS and foreign fightersNEW information about controversial domestic extremist groups like AntiFa, BLM, and the AltRight This edition retains the critical information that has made it the go-to guide for leaders and concerned citizens alike—from the history of American homeland defense from the nation’s earliest days to the events of 9/11, from and the birth of the Department of Homeland Security to the emergence of today’s vast homeland security enterprise. With the important updates in this edition, you will be even better prepared for terrorism and disasters.
Download or read book 101 Careers in Mathematics written by Andrew Sterrett and published by American Mathematical Soc.. This book was released on 2014-12-31 with total page 335 pages. Available in PDF, EPUB and Kindle. Book excerpt: This third edition of the immensely popular 101 Careers in Mathematics contains updates on the career paths of individuals profiled in the first and second editions, along with many new profiles. No career counselor should be without this valuable resource. The [Author];s of the essays in this volume describe a wide variety of careers for which a background in the mathematical sciences is useful. Each of the jobs presented shows real people in real jobs. Their individual histories demonstrate how the study of mathematics was useful in landing well-paying jobs in predictable places such as IBM, AT & T, and American Airlines, and in surprising places such as FedEx Corporation, L.L. Bean, and Perdue Farms, Inc. You will also learn about job opportunities in the Federal Government as well as exciting careers in the arts, sculpture, music, and television. There are really no limits to what you can do if you are well prepared in mathematics. The degrees earned by the [Author];s profiled here range from bachelor's to master's to PhD in approximately equal numbers. Most of the writers use the mathematical sciences on a daily basis in their work. Others rely on the general problem-solving skills acquired in mathematics as they deal with complex issues.
