Tag Archives: compliance

More Finger Pointing Over Sunshine System Snafus

Further delays in implementing the Open Payments program for disclosing industry financial relationships with prescribers has ignited a blame-game over who is at fault. The Centers for Medicare and Medicaid Services (CMS) is citing inaccurate data from pharma and medical device companies for the latest problems involving erroneous payment attributions. Manufacturers maintain they fully validate […]
Posted in Op-Ed, Regulatory | Also tagged , , , | Leave a comment

Eight Lessons for Enhancing Compliance Effectiveness in Europe

Andy Bender and Geert van Gansewinkel outline eight lessons for executing a soft change program for enhancing compliance effectiveness within European life sciences organizations. The European compliance and transparency landscape has changed rapidly over the last couple of years. Over and above the challenging compliance landscape, there is additional complexity impacting transparency relating to the […]
Posted in compliance, Europe, Global, Guest Blog | Also tagged , , | Leave a comment

Compliance Congress: Walking the Line

Pharma industry executives, FDA officials and Department of Justice attorneys speaking last week at CBI’s 11th annual Pharmaceutical Compliance Congress (PCC) offered solutions and threats to companies hoping to avoid enforcement actions.
Posted in Advertising, compliance, Emerging Markets, FDA, Global, Legal, Manufacturing, Marketing, People, Regulatory, Sales, Strategy, Technology | Also tagged , , , , , , , , , , , , | Leave a comment

Confessions of a Compliance Director

In anticipation of CBI’s (a PharmExec sibling company) 11th Annual Pharma Compliance Congress happening later this month, PharmExec spoke with a compliance director at a mid-sized pharma ($5 billion in annual sales) about life under a CIA, and the potential trigger issues for 2014. In an effort to promote candor and avoid overly circumspect responses, […]
Posted in compliance, Corporate Responsibility, E-Media, Emerging Markets, FDA, healthcare, Legal, Marketing, Medical Education, pricing, Regulatory, Sales, social media, Strategy | Also tagged , , , , , , , , , , , , , | Leave a comment

Putting a Price Tag on Compliance: Cheap Change or Big Bucks?

Compliance rules under the US Physician Payments Sunshine Act have been criticized for the excruciating level of detail demanded from individual company submissions.  But relatively little scrutiny has been accorded to another pressing question:  how much will all this new reporting cost?  The burden of compliance for not just this new law but in many […]
Posted in compliance, Marketing, Regulatory, Strategy | Also tagged , , , , | 1 Comment
  • Categories

  • Meta