Life sciences compliance, pricing, and contracting insights and updates has been saved
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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.
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?
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.
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.
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?
2021 life sciences regulatory outlook
Over the past several years, life sciences companies have faced mounting pressure from many directions, including increasing regulatory requirements, nonstop technological advances, and intense pricing pressure. And the unprecedented events of the past year only provided more reason to modernize compliance and elevate the value and partnerships within your companies and external stakeholders.
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.
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?
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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