Stay informed with expert insights, trends, and best practices in life sciences compliance.
Adherence to laws, regulations, and guidelines is vital for ensuring life sciences companies’ safety, efficacy, and ethical conduct. Even though life sciences companies are determined to bring breakthrough innovations to the market, complying with all applicable laws and regulations seems to be an imperative that cannot be disregarded. With the rising complexity of compliance functions […]
Conflicts of interest in the complex and highly regulated life sciences industry represent a critical challenge. Professionals in this sector must navigate a delicate balance between personal interests and ethical responsibilities. To maintain transparency and uphold ethical standards, the Centers for Medicare & Medicaid Services (CMS) Open Payments database emerges as a vital tool. In […]
We perform gap assessments in our daily lives without even realizing it. Take, for example, the simple act of meal planning. When planning a meal, you decide what you will eat, identify the necessary ingredients, check what you already have in your kitchen, and then list the necessary items. A trip to the grocery store […]
“Total penalties from compliance-related violations have surpassed $100 Billion in the last two decades.” Undoubtedly, the role of compliance officers is undergoing a profound transformation in response to the growing regulatory landscape and board scrutiny in the life sciences industry. This industry encompasses pharmaceuticals, biotechnology, and medical device manufacturers, and it goes without saying that […]
Ensuring adherence to Center for Medicaid and Medicare Services (CMS) requirements and maintaining transparency is important for life sciences companies. One critical aspect that demands attention is the correction and resolution of open payments disputes that are initiated by physicians, non-physician practitioners (NPPs), teaching hospitals all of which are collectively referred to as “covered recipients.” […]
As a compliance professional, you navigate a complex web of laws, regulations, and ethical considerations daily, safeguarding both your company’s reputation and the well-being of patients and consumers. But what makes a compliance program truly effective? How can you ensure that your efforts not only meet the necessary standards but also contribute to the growth […]
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