Category Archives: compliance
By Guest Blogger | Published: November 25, 2014
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.
By Pharm Exec | Published: November 20, 2014
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.
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 […]