Stay informed with expert insights, trends, and best practices in life sciences compliance.
Commercial compliance programs serve as the foundation of organizational integrity, ensuring adherence to all applicable rules and regulations specifically related to the company’s commercial activities. From the U.S. Department of Justice (DOJ) compliance mandates to the Office of Inspector General’s (OIG) enforcement-centric stance on third-party engagements, commercial compliance programs are designed not just for regulatory reporting but for […]
In the life sciences industry, ensuring regulatory compliance and effectively managing risks associated with healthcare professional (HCP) engagements are crucial. Recognizing that it is impractical to audit or monitor every interaction with HCPs, compliance teams need to use a risk-based approach to prioritize and focus on activities with a higher risk of compliance issues. Artificial […]
The U.S Department of Health and Human Services (HHS) Office of Inspector General (OIG) issued the General Compliance Program Guidance (GCPG) on November 6th – 2023, for life sciences companies and other industry verticals. The GCPG follows an earlier announcement by the OIG, which was associated with modernizing compliance programs. It also contains a few […]
Newly appointed compliance professionals cannot be expected to understand the hassle of manually auditing 100% of commercial expense data. With countless expenses to track and monitor against compliance SOPs, ensuring strict adherence to company policies and accurate and legitimate expense recording. Living in a technologically advanced era, leveraging modern tools to ensure life sciences compliance […]
“Total penalties from compliance-related violations have crossed over $20 Billion since 2000.” Ethical and law-compliant interaction between life sciences companies and healthcare professionals (HCPs) is key to avoiding the risk of regulatory penalties, fines, and other consequences. Authorities such as the U.S Department of Justice (DOJ) and the Office of Inspector General (OIG) have made it clear […]
Regulatory expectations and board scrutiny are increasing, and there’s also a growing pressure on compliance leaders to oversee a wider range of compliance activities. Compliance management revolves around making sure that an organization adheres to applicable laws, regulations, and internal ethics, standards, and policies. However, effective compliance programs go beyond mere legal adherence. Effective compliance […]
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