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Panelists at a recent virtual session of the DIA’s Europe 2020 conference identified the positive and negative aspects of Europe’s response to the pandemic, and suggested ways of avoiding shortages and making the supply chain more resilient in the event of future crises.
An EU pilot project will assess whether there is sufficient demand from companies to obtain simultaneous scientific advice from EU national competent authorities.
Erik Hansson remains deputy head of devices in a move to the European Commission’s DG Sante from DG Grow. He now answers to a newly appointed devices head who shares a common educational background but whose recent pharmaceutical role may unsettle the devices industry.
Bluebird bio’s gene therapy Zynteglo, Akcea’s antisense drug Waylivra and BioMarin’s enzyme substitution therapy Palynziq were among the novel innovative medicines that were approved in Europe in 2019.
An interactive timeline of HBW Insight's coverage of the blossoming European CBD market in 2019. The timeline covers the main events of the year beginning with the European Commission's decision to classify CBD as a novel food, and ending on the filing of the first application for a synthetic form of the cannabis-derived ingredient.
Medtech industry gets best seasonal gift as Council of EU and European Parliament agree on longer transition period for upclassified Class I medical devices. But how many notified bodies are still auditing products under the medical device directives?
Only just over a month ago there were fears that the implementation of the EU Medical Device Regulation was going to be hampered by a lack of expert panel applicants. Now it seems there is no shortage. The news raises lots of questions about when and how the structure will now work.
The two-year delay to Eudamed was a Commission decision. Now the competent authorities are fighting back and the issue is to be discussed at the level of the Council of the European Union on December 9 to avoid “heavily burdensome administrative transitional solutions.”
There may have been a significant increase in the amount of regulatory activity at EU level of late, but the medtech industry remains alarmed at the lack of readiness of the system, and calls for an urgent focus on IVDs now too.
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