Category Archives: compliance
By Michael Christel | Published: July 7, 2014
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.
By Guest Blogger | Published: July 1, 2014
By Ken Ribotsky. Pharmaceutical companies have begun using social media for business needs and promotion, yet have been hesitant to become too engaged since the FDA’s stance on social media activity remained unclear. But now that we know the FDA’s specific guidelines for pharma companies’ actions online, it’s time for brands to consider diving into […]
By Guest Blogger | Published: June 23, 2014
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 […]
By Guest Blogger | Published: April 28, 2014
New data maintenance guidelines have sparked a flurry of activity in Europe. Organizations are still grappling with electronic submissions, and the need to update data is intensifying the pressure. But there is an upside, says Miranda Pothiawala. Earlier this year formal guidelines on how to maintain and update data submitted to the extended EudraVigilance Medicinal […]
By Ben Comer | Published: February 6, 2014
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.