Pharmaceutical and Medical Device Compliance Manual
Pharmaceutical and Medical Device Compliance Manual

Author: Ela Bochenek

Publisher:

Published: 2019

Total Pages: 319

ISBN-13: 9781522178026

DOWNLOAD EBOOK

A robust compliance program is essential to protecting a company from running afoul of the myriad laws and regulations that have been enacted to combat fraud and waste. The second edition of the Pharmaceutical and Medical Device Compliance Manual includes guidance to help companies develop a compliance program tailored to today's complex enforcement and business environment. Study of this Manual will enable compliance professionals and lawyers to understand the government's expectations of an effective compliance program and ethical business practices, as well as: how the government discovers potential enforcement actions, its approach to pursuing such actions, what behaviors can constitute mitigating factors for a company in the event of a legal violation. Coverage includes new chapters covering:Pharmaceutical industry interactions with patient organizations Compliance 2.0: compliance analytics in the era of big dataThe art and science of health care compliance in the pharmaceutical and medical device industries The Manual will be a great tool for health and life sciences attorneys, compliance officers, and others in the pharmaceutical and medical devices industry

Cobert's Manual Of Drug Safety And Pharmacovigilance (Third Edition)
Cobert's Manual Of Drug Safety And Pharmacovigilance (Third Edition)

Author: Barton Cobert

Publisher: World Scientific

Published: 2019-04-09

Total Pages: 525

ISBN-13: 9813279168

DOWNLOAD EBOOK

Completely revised and updated, Cobert's Manual of Drug Safety and Pharmacovigilance, Third Edition, is a how-to manual for those working in the fields of drug safety, clinical research, pharmacology, regulatory affairs, risk management, quality/compliance, and in government and legal professions.This comprehensive and practical guide discusses the theory and the practicalities of drug safety (also known as pharmacovigilance), and provides essential information on drug safety and regulations in the United States, Europe Union, and more, including: recognizing, monitoring, reporting, and cataloging serious adverse drug reactions.Cobert's Manual of Drug Safety and Pharmacovigilance, Third Edition, teaches the daily practice of drug safety in industry, hospitals, the FDA and other health agencies — both in the United States and around the world — and provides critical information about what to do when confronted with a drug safety problem.Related Link(s)

When Good Drugs Go Bad
When Good Drugs Go Bad

Author: Dan Malleck

Publisher: UBC Press

Published: 2015-07-15

Total Pages: 321

ISBN-13: 0774829222

DOWNLOAD EBOOK

Throughout the 1800s, opium and cocaine could be easily obtained to treat a range of ailments in Canada. Dependency, when it occurred, was considered a matter of personal vice. Near the end of the century, attitudes shifted and access to drugs became more restricted. How did this happen? Dan Malleck examines the conditions that led to Canada’s current drug laws. Drawing on newspaper accounts, medical and pharmacy journals, professional association files, asylum documents, physicians’ case books, and pharmacy records, Malleck demonstrates how a number of social, economic, and cultural forces converged in the early 1900s to influence lawmakers and criminalize addiction. His research exposes how social concerns about drug addiction had less to do with the long pipe and shadowy den than with lobbying by medical professionals, a growing pharmaceutical industry, and concern about the morality and future of the nation.

Pharmacy Practice and the Law
Pharmacy Practice and the Law

Author: Richard R. Abood

Publisher: Jones & Bartlett Learning

Published: 2005

Total Pages: 408

ISBN-13: 9780763747244

DOWNLOAD EBOOK

Pharmacy Practice and the Law creates a solid overview of pharmacy law, incorporating relevant case laws and historical backgrounds of why and how specific laws developed. The new Fourth Edition stimulates critical thinking issues in pharmacy law and explains the federal and state pharmacy regulation that corresponds to recent directives of the American Association of Colleges of Pharmacy. This text serves as a tool to pass the law portion of a board examination, and helps students develop as practitioners, contributors andleaders to the profession itself.