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AHLA Pharmaceutical and Medical Device Compliance Manual (AHLA Members)

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Print Book :Softbound, 308 pages
2nd Edition
ISBN/ISSN: 9781522178019
Release Date: August 22, 2019
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$175.00
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2nd Edition
ISBN/ISSN: 9781522178033
Release Date: July 24, 2019
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eBook :epub
2nd Edition
ISBN/ISSN: 9781522178033
Release Date: July 24, 2019
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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 data
  • The 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.

Proudly published with Seton Hall Law School.

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Table of contents

 Introduction to the Second Edition 

About the Editors

About the Authors

About AHLA and Seton Hall Law School's Center for Health & Pharmaceutical Law &
Policy

Acknowledgments


1    Enforcement Authorities

2    Thou Shalt Not Buy Business: The Implications of the Anti-Kickback Statute on the
       Drug and Device Industry

3    False Claims Act

4    Advertising, Labeling, and Promotion

5    Drug and Device Development and Approval

6    Federal Health Care Programs: Coverage and Reimbursement of Prescription Drugs
       and Medical Devices

7    International Anti-Bribery and Anti-Corruption Laws

8    Major Privacy Laws and Their Impact on Life Sciences Companies

9    Federal and State Transparency Laws

10    Elements of an Effective Compliance Program

11    Prescription Drug Price Regulation

12    Pharmaceutical Industry Interactions with Patient organizations: Defining
          Regulatory Parameters

13    Compliance 2.0: Compliance Analytics in the Era of Big Data

14    The Art And Science of Health Care Compliance in The Pharmaceutical and Medical
          Device Industries