Pharmaceutical Compliance and Enforcement Answer Book
Author : Howard L. Dorfman
Publisher :
Page : 0 pages
File Size : 18,18 MB
Release : 2024
Category : Drugs
ISBN : 9781402446047
Author : Howard L. Dorfman
Publisher :
Page : 0 pages
File Size : 18,18 MB
Release : 2024
Category : Drugs
ISBN : 9781402446047
Author : Howard L. Dorfman
Publisher :
Page : 0 pages
File Size : 37,72 MB
Release : 2024
Category : Drugs
ISBN : 9781402446047
Author : Christopher A. Myers
Publisher :
Page : 2384 pages
File Size : 30,74 MB
Release : 2018-11
Category : Auditing, Internal
ISBN : 9781402431197
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 : Suzan Onel
Publisher :
Page : 0 pages
File Size : 32,44 MB
Release : 2022
Category : Medical instruments and apparatus
ISBN : 9781402441622
Author : Andrew L. Bab
Publisher :
Page : 0 pages
File Size : 39,49 MB
Release : 2016-10-07
Category : Consolidation and merger of corporations
ISBN : 9781402426322
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 : Howard L. Dorfman
Publisher :
Page : 0 pages
File Size : 40,38 MB
Release : 2018-07-03
Category : Drugs
ISBN : 9781402431395
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 :
Page : 0 pages
File Size : 30,31 MB
Release : 2015-05-07
Category : Drugs
ISBN : 9781402423727
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 :
Page : 0 pages
File Size : 16,74 MB
Release : 2021-09-30
Category : Medical
ISBN : 9781585286294
"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 :
Page : 32 pages
File Size : 23,65 MB
Release : 1998
Category : Advertising
ISBN :
Author : Mike Koehler
Publisher : Edward Elgar Publishing
Page : 304 pages
File Size : 15,62 MB
Release : 2018-11-30
Category : Business & Economics
ISBN : 1788114930
In the minds of some, complying with the U.S. Foreign Corrupt Practices Act and related laws is easy: 'you just don't bribe.' The reality, as sophisticated professionals should know, is not so simple. This book is for professionals across various disciplines who can assist in risk management and want to learn strategies for minimizing risk under aggressively enforced bribery laws. Written by a leading expert with real-world practice experience, this book elevates knowledge and skills through a comprehensive analysis of all legal authority and other relevant sources of information. It also guides readers through various components of compliance best practices from the fundamentals of conducting a risk assessment, to effectively communicating compliance expectations, to implementing and overseeing compliance strategies. With a focus on active learning, this book allows readers to assess their acquired knowledge through various issue-spotting scenarios and skills exercises and thereby gain confidence in their specific job functions. Anyone seeking an informed and comprehensive understanding of the modern era of enforcement of bribery laws and related risk management strategies will find this book to be a valuable resource including in-house compliance personnel, FCPA and related practitioners, board of director members and executive officers.