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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Discover compliance and risk management changes in our 2025 Life sciences regulatory outlook
In 2025, regulatory and compliance functions within life sciences organizations are poised for significant technical transformation. As organizations embrace these advancements, they will need to strengthen governance and monitoring frameworks to address ethical concerns, privacy issues, and potential biases associated with emerging technologies.
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Regulatory insights on AI and Generative AI in the medtech industry
The medtech industry needs to navigate the regulatory landscape carefully while scaling AI and GenAI for transformation.
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Continuous monitoring in life sciences: Enhancing compliance through real-time risk management
Continuous monitoring is vital for achieving robust compliance and effective risk management within the life sciences sector.
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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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Harnessing Tech to Elevate Third-Party Bribery, Corruption Risk Management Programs
Tech-enablement, when done correctly, can help improve the effectiveness of a risk management program while helping to manage budgets and handle change management and user adoption
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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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Third-Party Due Diligence: 3 Steps to Evaluate Bribery, Corruption Risk
A heightened regulatory focus coupled with increased virtual assessments will likely drive organizations to take a more structured, tech-enabled approach to managing high-risk third parties
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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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Life sciences companies: Are you managing your contracts with health care providers effectively?
In this article, we’ll explore health care professional (HCP) contracting processes and their associated potential risks to be considered. We will also share considerations to streamline the process that allows life sciences companies to potentially improve compliance, reduce their operational burden, and maximize the value they get from the HCP relationships.
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Future of Work: Ways of working in uncertain times
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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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