Category Archives: Europe
By Guest Blogger | Published: December 1, 2014
The innovation debate (Why isn’t there more or it? How much should we pay for it? Just what is it anyway?!) remains a lively one in the UK. Lord Saatchi’s Medical Innovation Bill is just one part of this debate. It’s intended to mitigate against so called ‘defensive’ medicine, where clinicians might not prescribe or […]
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 Guest Blogger | Published: November 17, 2014
Peter O’Donnell’s recent Applied Clinical Trials blog, ‘Who’s in charge of Medicines in Brussels?‘, has been overtaken by history, with the departure of Guido Rasi from his post of Executive Director of the European Medicines Agency. At a time of flux in the European context for pharmaceuticals, Rasi’s moderate manner and capacity for strategic thinking […]
By Pharm Exec | Published: November 14, 2014
In response to a letter the European Medicines Agency received from the European Ombudsman on Oct. 27, 2014, the agency is clarifying its policy on commercially confidential information. EMA states in its response that the agency is responsible for ruling on redactions of published documents and bases its decisions in accordance with laws and internal […]