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40 Total results for product and free and sample content found
Medtech Insight
By Amanda Maxwell 27 Feb 2019
The UK government is introducing new registration requirements for medical devices in the event of a no-deal Brexit. They will be rolled out according to the risk class of products. But some fundamental questions have arisen.
Scrip
By Jo Shorthouse 01 Feb 2019
As the EMA lowers the flags of the 28 EU nations that have flown outside its London offices for 24 years, and prepares to moves its HQ to the Netherlands, Scrip takes a look at Europe’s new pharma regulatory hub.
Topic Business strategies Brexit
Pink Sheet
By Ian Schofield 23 Jan 2019
The BioIndustry Association wants the government to rule out a “no-deal” Brexit, saying it would be bad for patients and the life sciences sector.
Medtech Insight
By Amanda Maxwell 10 Jan 2019
The recent no-deal Brexit notice from the UK government says that companies selling devices in the UK would need a "Responsible Person" in the UK if the firm is not based there. The government clarifies to Medtech Insight that such person must be physically present in the UK, and not simply have an address there.
Topic Brexit
Medtech Insight
By Amanda Maxwell 05 Dec 2018
The medtech sector was already quite overwhelmed with the new EU regulations and Brexit uncertainties. Now add into the mix the impact of the global journalistic Implant Files investigation.
Pink Sheet
By Maureen Kenny 12 Sep 2018
Clusters of excellence, competition as well as co-operation, Brexit, and aiming high. Danish Medicines Agency head Thomas Senderovitz talks national agencies and engagement in an interview with the Pink Sheet.
Pink Sheet
By Maureen Kenny 12 Sep 2018
The European Medicines Agency and drug regulators throughout the EU are having to invest huge amounts of time and effort in dealing with the fall-out from Brexit - and it hasn't even happened yet. Plans for working together on bigger issues agreed on a few years ago will likely have to change, senior regulator Thomas Senderovitz tells the Pink Sheet.
Topic Brexit Business strategies
Pink Sheet
By Maureen Kenny 12 Sep 2018
Changing mindsets, technologies outpacing regulatory frameworks, intense international collaboration, and the future of the randomized controlled clinical trial. Big data is forcing us to think big, senior European regulator Thomas Senderovitz tells the Pink Sheet.
Topic Brexit Business strategies
Medtech Insight
By Amanda Maxwell 30 Aug 2018
With the pressure increasing on manufacturers to have their products reassessed under the current EU medical devices directives or under the new EU regulations, where can capacity be found?
Topic Brexit Business strategies
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