Pharmaceutial and Medical Device Law, published by the ABA Health Law Section and Bloomberg BNA, provides readers with an overview of key legal and regulatory issues that impact the development and marketing activities of pharmaceutical and medical device companies.
Carol Poindexter, Paul Sumilas and Vijay Rao have contributed to Chapter 8 (Federal Sentencing Guidelines and Compliance Measures), which covers topics such as
- How to structure and manage compliance programs to meet government regulator expectations.
- Strategies for managing investigations and navigating disclosure issues.
- Potential individual liability for the board of directors and senior management.
- Standards and best practices for compliance as set of forth in industry guidance.
A new era for Whistleblowers in Australia
Amendments to the laws have passed both Commonwealth Houses of Parliament.