Tag Archives: transparency

The Year of Living Openly: Europe and Transparency 2015

The past year has brought significant changes not only in regulatory mandates and guidances but also regarding a broader overall emphasis on coordination of information and processes. The regulators have prioritized transparency and harmonization for some time but underscored them to an even greater degree in 2014; 2015 is likely to see the trend intensify.
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EMA Revises Conflict-of-Interest Policy

The European Medicines Agency (EMA) has published its revised policy on handling declarations of interests for scientific-committee members and experts. The revisions strive for a more balanced approach in restricting the involvement of experts with possible conflicts of interests in the Agency’s work, while maintaining access to expertise.
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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 […]
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Open Payments: A New Dawn for Transparency

The Physicians Payment Sunshine Act, more formally referred to as Open Payments, has been in place for almost 18 months. It is only in the next few months, however, that the implications of the law and its contentious requirements will start to be fully realised. Michael Christel reports.
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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 […]
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