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The EU Medical Devices Regulation (MDR) brought about new post-market clinical follow-up (PMCF) requirements for medical devices. Whereas complaint monitoring and literature searches were often sufficient under the Medical Devices Directives (MDD),…
As my 1-year term as the EMWA president is ending, I would like to say that it has been a great year! Manchester and Barcelona were incredible successes. The Executive Committee is working hard to improve all aspects of the EMWA, and, thanks to…
Activities around clinical documents disclosure have been slow since September 2018 when I last published this section. As many of you receive emails from the CORE Reference website (sign up at https://www.core-reference.org/subscribe), you have…
EMA published their first report on the Policy 0070 publication of clinical data ( July 16, 2018): https://www.ema.europa.eu/documents/report /clinical-data-publication-policy-0070-reportoct- 2016-oct-2017_en.pdf. Over the period October 2016 to…
With increasing transparency demands andthe new legal requirements for providingclinical trial information to lay readers, clinicaltrials need to be given titles that patients canunderstand and recognise. Trial titles informthe readers what the…
In January 2021, the single market of medicines of the Eurasian Economic Union (EAEU) was launched. This article describes the current status of the transition to unified rules for the registration of medicinal products and the main regulatory…
The 45th EMWA Conference in Cascais, Portugal, has recently finished and we are all waiting for the upcoming annual event in Barcelona, Spain, next Spring. In the meantime, the Executive Committee is working hard on improving what EMWA has to offer…
Many medical writers and translators are not members of professional associations. While online networking is clearly accepted as a key element for success in business, the benefits of joining associations are still not obvious to all, even though…
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