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Tag Archives: EMA
Ethics in Drug Innovation: The First Hurdle is Trust
By Ansis Helmanis
Ethics is a matter of trust, which in the regulatory space requires transparency and openness among all stakeholders, including patients and industry. This was the consensus of FDA Commissioner Margaret Hamburg and European Medicines Agency (EMA) Executive Director Guido Rasi, both of whom shared the podium with Nobel Laureate Professor Elie Wiesel [...]
Posted in Europe, Events, FDA, Global, Guest Blog, Market Access, Patient Communication, Regulatory, healthcare, leadership, pricing Also tagged CMS, Elie Wiesel, FDA, Guido Rasi, Margaret Hamburg, Prix Galien, reimbursement, sequestration Leave a comment
Former EMA Head Back in the Regulatory Saddle
His decade-long tenure as head of the European Medicines Agency (EMA) may have ended, but Thomas Lönngren is already back in the regulatory saddle as a strategic advisor to NDA Group, an independent consulting group focused on reducing wasted drug development costs, ensuring new medicines get to market faster, and “improving the performance of the [...]
Posted in Europe, Global, Market Access, People, R&D, Regulatory, leadership, pricing Also tagged Market Access, Regulatory, Strategy, Thomas Lönngren Leave a comment
Exclusive Interview: The European Medicine Agency's Thomas Lönngren
The European Medicines Agency (EMA) is a unique institution, pursuing a mandate shared with a complex web of national and regional groups, each able to place a distinctive imprint around the delicate task of certifying the safety and efficacy of new drugs. In return, EMA has made a virtue of necessity. It filled the regulatory [...]
Posted in Europe, Global, People, Regulatory, leadership Also tagged EU, European Medicines Agency, Regulatory, Thomas Lönngren 2 Comments
The Year to Come: EMA's Plans Announced