AHLA Pharmaceutical and Medical Device Compliance Manual (AHLA Members)
Published with Seton Hall Law School. Compliance professionals in the pharmaceutical and medical device industries face not only evolving and expanding duties, but also growing scrutiny from state, federal, and international regulators. This Manual synthesizes what can be an overwhelming quantity of authority into understandable analysis and practical action.
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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.
Published in September, 2019.
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 &
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
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