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Government Investigations Compliance Monitoring

Goodwin

Common FDA Bioresearch Monitoring (BIMO) Violations: Updates from FY 2023 to Now

Goodwin on

The Bioresearch Monitoring (BIMO) Program, operated by the U.S. Food and Drug Administration (FDA), conducts on-site inspections and data audits in order to effectively monitor the compliance of all FDA-regulated research....more

Arnall Golden Gregory LLP

Q&A With Allison Raley: Defending Against Government Investigations

Q: What are the primary areas of focus in your practice related to government investigations? A: My practice primarily focuses on defense against enforcement actions brought by regulatory bodies such as the Office of Foreign...more

Health Care Compliance Association (HCCA)

Preparing for a Government Healthcare Audit

Jessica Zeff loves government audits. It’s hard to believe, given the dread they inspire. But, the founder and lead consultant of Simply Compliance makes a very good case in this podcast that audits can be much better than...more

Eversheds Sutherland (US) LLP

US Department of Justice adopts “bold” approach to prosecuting corporate crime and will engage in “rigorous enforcement”

On October 28, 2021, Deputy Attorney General (Deputy AG) Lisa O. Monaco gave remarks explicitly warning companies that the US Department of Justice (DOJ) intends to increase its efforts and devote additional resources to...more

Society of Corporate Compliance and Ethics...

[Webinar] Truth or Consequences: Demonstrating Regulator Ready Compliance Plans vs Consequences of “First Draft” Plans - July...

Main Points Covered: - Elements of a regulator’s thought process: understanding the use of your compliance information (or lack thereof) to determine consequences - Ways to demonstrate plan effectiveness for government...more

Morgan Lewis

UK Serious Fraud Office Emphasizes Importance of Compliance Programs

Morgan Lewis on

In a recent update to its internal guidance, the UK Serious Fraud Office provides insight into the general approach its investigators may take for evaluating organizations’ compliance programs—an approach similar to that of...more

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