EMA Addresses Early, Asymptomatic Alzheimer’s In ‘Hugely Important’ Clinical Study Guidance
The European Medicines Agency expects its revised guidance to facilitate the development of medicines to prevent and treat Alzheimer’s disease.
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The European Medicines Agency chief Guido Rasi is worried that if work on guidance development and revision stutters, "the whole system may suffer."
The European Patent Office has adjusted the starting date of its transitional measures for applicants that want their patent to have unitary effect under the coming Unified Patent Court system.
New EMA Innovation Group To Provide Point Of Entry For Developers & Contribute To Regulatory Assessments
The European Medicines Agency’s newly established Quality Innovation Expert Group will focus on innovative pharmaceutical manufacturing approaches, starting with continuous manufacturing for biologicals and end-to-end processes, and decentralized manufacturing.