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Author : Howard L. Dorfman
Publisher :
ISBN 13 : 9781402446047
Total Pages : 0 pages
Book Rating : 4.4/5 (46 download)
Download or read book Pharmaceutical Compliance and Enforcement Answer Book written by Howard L. Dorfman and published by . This book was released on 2024 with total page 0 pages. Available in PDF, EPUB and Kindle. Book excerpt:
Author : Howard L. Dorfman
Publisher :
ISBN 13 : 9781402438486
Total Pages : pages
Book Rating : 4.4/5 (384 download)
Download or read book Pharmaceutical Compliance and Enforcement Answer Book written by Howard L. Dorfman and published by . This book was released on 2021 with total page pages. Available in PDF, EPUB and Kindle. Book excerpt:
Author : Christopher A. Myers
Publisher :
ISBN 13 : 9781402431197
Total Pages : 2384 pages
Book Rating : 4.4/5 (311 download)
Download or read book Corporate Compliance Answer Book written by Christopher A. Myers and published by . This book was released on 2018-11 with total page 2384 pages. Available in PDF, EPUB and Kindle. Book excerpt: Representing the combined work of more than forty leading compliance attorneys, Corporate Compliance Answer Book helps you develop, implement, and enforce compliance programs that detect and prevent wrongdoing. You'll learn how to: Use risk assessment to pinpoint and reduce your company's areas of legal exposureApply gap analysis to detect and eliminate flaws in your compliance programConduct internal investigations that prevent legal problems from becoming major crisesDevelop records management programs that prepare you for the e-discovery involved in investigations and litigationSatisfy labor and employment mandates, environmental rules, lobbying and campaign finance laws, export control regulations, and FCPA anti-bribery standardsMake voluntary disclosures and cooperate with government agencies in ways that mitigate the legal, financial and reputational damages caused by violationsFeaturing dozens of real-world case studies, charts, tables, compliance checklists, and best practice tips, Corporate Compliance Answer Book pays for itself over and over again by helping you avoid major legal and financial burdens.
Author : Andrew L. Bab
Publisher :
ISBN 13 : 9781402426322
Total Pages : 0 pages
Book Rating : 4.4/5 (263 download)
Download or read book Health Care Mergers and Acquisitions Answer Book written by Andrew L. Bab and published by . This book was released on 2016-10-07 with total page 0 pages. Available in PDF, EPUB and Kindle. Book excerpt: M&A activity in the health care industry is at its highest level since the 1980s. Organized into four parts, this guide includes practical advice on how to address the various industry-specific issues arising in health care acquisitions.
Author : Suzan Onel
Publisher :
ISBN 13 : 9781402441622
Total Pages : 0 pages
Book Rating : 4.4/5 (416 download)
Download or read book Medical Devices Law and Regulation Answer Book written by Suzan Onel and published by . This book was released on 2022 with total page 0 pages. Available in PDF, EPUB and Kindle. Book excerpt:
Author : Howard L. Dorfman
Publisher :
ISBN 13 : 9781402431395
Total Pages : 0 pages
Book Rating : 4.4/5 (313 download)
Download or read book Pharmaceutical Compliance and Enforcement Answer Book written by Howard L. Dorfman and published by . This book was released on 2018-07-03 with total page 0 pages. Available in PDF, EPUB and Kindle. Book excerpt: Pharmaceutical Compliance and Enforcement Answer Book provides a comprehensive overview of the regulatory issues faced by the different participants in the pharmaceutical industry.In an easy Q&A format, this resource discusses: The FDA's authority and potential actions to regulate prescription drugs and biologics both before and after approval by the agencyA facility's rights and compliance obligations during an inspection by the agencyHow to best evaluate a company's potential of being in violation and what to do to mitigate those risksWhat advertising and promotion of prescription drugs is permittedHow product liability issues overlap with FDA enforcement initiativesWhen criminal prosecution is used as part of the regulatory enforcement effortFilled with practical suggestions, Pharmaceutical Compliance and Enforcement Answer Book provides attorneys and compliance officers with a roadmap to effective compliance with FDA pharmaceutical regulations.
Author : Howard L. Dorfman
Publisher :
ISBN 13 : 9781402423727
Total Pages : 0 pages
Book Rating : 4.4/5 (237 download)
Download or read book Pharmaceutical Compliance and Enforcement Answer Book 2015 written by Howard L. Dorfman and published by . This book was released on 2015-05-07 with total page 0 pages. Available in PDF, EPUB and Kindle. Book excerpt: In an easy Q&A format, Pharmaceutical Compliance and Enforcement Answer Book 2015 describes: -The FDA's authority and potential actions to regulate prescription drugs and biologics -A facility's rights and compliance obligations -What advertising and promotion of prescription drugs is permitted -How product liability issues overlap with FDA enforcement -When criminal prosecution is used
Author : Patricia C. Kienle
Publisher :
ISBN 13 : 9781585286294
Total Pages : 0 pages
Book Rating : 4.2/5 (862 download)
Download or read book The Chapter 800 Answer Book written by Patricia C. Kienle and published by . This book was released on 2021-09-30 with total page 0 pages. Available in PDF, EPUB and Kindle. Book excerpt: "Provides explanation of elements of USP Hazardous Drugs' Handling in Healthcare Settings and best practices to comply with the requirements and recommendations of the USP General Chapter"--Pref.
Author : United States. Federal Trade Commission. Bureau of Consumer Protection
Publisher :
ISBN 13 :
Total Pages : 32 pages
Book Rating : 4.:/5 (31 download)
Download or read book Dietary Supplements written by United States. Federal Trade Commission. Bureau of Consumer Protection and published by . This book was released on 1998 with total page 32 pages. Available in PDF, EPUB and Kindle. Book excerpt:
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)
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.
Author : Benjamin van Rooij
Publisher : Cambridge University Press
ISBN 13 : 1108754139
Total Pages : 1559 pages
Book Rating : 4.1/5 (87 download)
Download or read book The Cambridge Handbook of Compliance written by Benjamin van Rooij and published by Cambridge University Press. This book was released on 2021-05-20 with total page 1559 pages. Available in PDF, EPUB and Kindle. Book excerpt: Compliance has become key to our contemporary markets, societies, and modes of governance across a variety of public and private domains. While this has stimulated a rich body of empirical and practical expertise on compliance, thus far, there has been no comprehensive understanding of what compliance is or how it influences various fields and sectors. The academic knowledge of compliance has remained siloed along different disciplinary domains, regulatory and legal spheres, and mechanisms and interventions. This handbook bridges these divides to provide the first one-stop overview of what compliance is, how we can best study it, and the core mechanisms that shape it. Written by leading experts, chapters offer perspectives from across law, regulatory studies, management science, criminology, economics, sociology, and psychology. This volume is the definitive and comprehensive account of compliance.
Author : Ian Ayres
Publisher : Oxford University Press
ISBN 13 : 0199879958
Total Pages : 216 pages
Book Rating : 4.1/5 (998 download)
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.
Author : Graham Dukes
Publisher : Edward Elgar Publishing
ISBN 13 : 1783471107
Total Pages : 419 pages
Book Rating : 4.7/5 (834 download)
Download or read book Pharmaceuticals, Corporate Crime and Public Health written by Graham Dukes and published by Edward Elgar Publishing. This book was released on 2014-06-27 with total page 419 pages. Available in PDF, EPUB and Kindle. Book excerpt: The pharmaceutical industry exists to serve the community, but over the years it has engaged massively in corporate crime, with the public footing the bill. This readable study by experts in medicine, law, criminology and public health documents the pr
Author : John Braithwaite
Publisher : Routledge
ISBN 13 : 1135072906
Total Pages : 451 pages
Book Rating : 4.1/5 (35 download)
Download or read book Corporate Crime in the Pharmaceutical Industry (Routledge Revivals) written by John Braithwaite and published by Routledge. This book was released on 2013-10-08 with total page 451 pages. Available in PDF, EPUB and Kindle. Book excerpt: First published in 1984, this book examines corporate crime in the pharmaceutical industry. Based on extensive research, including interviews with 131 senior executives of pharmaceutical companies in the United States, the United Kingdom, Australia, Mexico and Guatemala, the book is a major study of white-collar crime. Written in the 1980s, it covers topics such as international bribery and corruption, fraud in the testing of drugs and criminal negligence in the unsafe manufacturing of drugs. The author considers the implications of his findings for a range of strategies to control corporate crime, nationally and internationally.
Author : David Mantus
Publisher : CRC Press
ISBN 13 : 1841849200
Total Pages : 401 pages
Book Rating : 4.8/5 (418 download)
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 401 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.
Author : U. S. Customs and Border Protection
Publisher :
ISBN 13 : 9781304100061
Total Pages : 0 pages
Book Rating : 4.1/5 ( download)
Download or read book Importing Into the United States written by U. S. Customs and Border Protection and published by . This book was released on 2015-10-12 with total page 0 pages. Available in PDF, EPUB and Kindle. Book excerpt: Explains process of importing goods into the U.S., including informed compliance, invoices, duty assessments, classification and value, marking requirements, etc.
Author : Yuval Feldman
Publisher :
ISBN 13 : 1107137101
Total Pages : 257 pages
Book Rating : 4.1/5 (71 download)
Download or read book The Law of Good People written by Yuval Feldman and published by . This book was released on 2018-06-07 with total page 257 pages. Available in PDF, EPUB and Kindle. Book excerpt: This book argues that overcoming people's inability to recognize their own wrongdoing is the most important but regrettably neglected area of the behavioral approach to law.
