Amplifying the Patient Voice: Reflections from MAPS EMEA 2025
At this year’s MAPS EMEA 2025 Annual Meeting in London, the message was clear: the patient voice is central to every stage of the drug development journey, a theme eloquently showcased in the Opening General Assembly: Patient Impact on Medical Affairs. Global leaders in Medical Affairs gathered to explore how the industry can evolve from…...
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Periodic Safety Update Report (PSUR): A Breakdown of MDCG 2022-21
A well-structured, clear, and concise PSUR enables a seamless notified body review. Read our key...
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Ensuring the safety and functionality of your medical device is vital. But how much clinical...
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An ideal PMCF plan, with reference to MDCG 2020-7, presents the general and specific methods...
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With the MDR coming into effect, the manufacturers should plan and construct their strategy to...
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Session summaries from EUMDR exchange conference 2021...
Digital Therapeutics and Medical Communications: Are We Ready?
Digital Therapeutics are very new and complex, and their use will involve changing standard therapeutic...