Life sciences compliance, pricing, and contracting insights and updates has been saved
Perspectives
Life sciences compliance, pricing, and contracting insights and updates
Thought leadership collection
Life sciences compliance teams face escalating responsibilities. From strategic innovation to operational excellence, keeping up with rapidly changing regulatory environments and industry guidelines is crucial. We have developed this collection of insights and informative updates with a focus on critical issues for today’s compliance professionals.
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Leveraging tech-enabled solutions to support OIG Compliance Program Guidance implementation for life sciences companies
Exploring avenues to incorporate GenAI into the strategic evaluation of compliance programs has the potential to provide significant value to companies in providing real-time risk evaluation and help equip Compliance and other functions to remedy swiftly and proactively.
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Life Sciences: Deciphering Fair Market Value for Digital Opinion Leaders
Compensation arrangements between life sciences companies and DOLs require a new calculus that considers online engagement metrics and more.
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Generative AI regulations in life sciences
While Generative AI (GenAI) has much promise, the global AI regulatory environment could pose challenges for the life sciences industry. Clarity in the regulatory environment can help accelerate the AI journey and adoption across regions. Explore the regulatory environment of AI in six geographical jurisdictions.
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All parties are not created equal: Managing high-risk third parties
Many organizations that operate in the pharmaceutical and medical technology sectors often find out too late that some of the third parties with which they do business may represent a direct and costly risk to their own business.
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New opportunities for compliance in life sciences and health care
Life sciences and health care organizations need to establish and maintain trust to operate—and compliance is essential to that trust. As the environment for these industries grows increasingly pressured in 2024 and beyond, it’s no longer enough to follow the rules, check the boxes, and investigate any failings.
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2022 life sciences regulatory outlook: Updates, trends, and changes impacting compliance leaders in 2022
Explore observations, trends, and actions to consider that may have an impact on new legislative and regulatory changes, as well as your role and focus areas. You’ll also gain insight into the digital tools and practices that compliance teams are using to stay relevant, reduce risk, and build resilience to have a positive impact now and into the future.
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Keeping an eye on virtual interactions in life sciences: The next verse of communications monitoring
Access to artificial intelligence (AI)-powered tools and flexible automation workflows has revolutionized how monitoring activities are performed—teams are now finding more relevant information in significantly less time. So, what’s next?
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Keep up on MedTech industry compliance: A summary of the June 2022 update of the AdvaMed Code
On March 24, 2022, the Advanced Medical and Technology Association (“AdvaMed”) announced that it updated its Code of Ethics on Interactions with Health Care Professionals (HCPs) in the United States. Learn more about the compliance guidance updates for MedTech companies and the six new FAQs AdvaMed added to clarify critical concepts.
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New and changing state price transparency regulations
Many US states have enacted new state drug price transparency legislation or amended current legislation to address prescription drug costs and spending, which poses operational challenges for manufacturers to maintain compliance with these new requirements. Explore this report to understand how this legislation may impact your unique business requirements.
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Future of Work: Ways of working in uncertain times
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PhRMA code update on Speaker programs
On August 6, 2021, the Pharmaceutical Research and Manufacturers of America (PhRMA) announced that it updated its Code on Interactions with Health Care Professionals (“PhRMA Code”). The changes included in this update primarily focus on company-sponsored speaker programs. What are the new insertions into the PhRMA Code and some of the other critical changes?
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Office of Inspector General (OIG) releases special fraud alert for speaker programs
The Special Fraud Alert: Speaker Programs was released to “highlight the fraud and abuse risks associated with the offer, payment, solicitation, or receipt of renumeration relating to speaker programs by pharmaceutical and medical device companies.” What does it mean for life sciences organizations and what actions should you consider taking?
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Pharmacy Benefit Manager (PBM) final rule delayed again: What now?
Pharmacy Benefit Manager (PBM) final rule delayed again: What now?
While the PBM final rule is delayed, it is important for pharmaceutical manufacturers to continue to evaluate their current service arrangements (including PBM agreements) from a bona fide service fee (BFSF) and fair market value (FMV) perspective.
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