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39 Total results for product and free and sample content found

Scrip: 世界の医療用医薬品&製薬産業に関するニュース

Infographic: The Netherlands, A Small Country With Big Ideas

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: 世界の薬事規制と承認審査に関するニュース

'Rule Out No-Deal Brexit,' BIA Tells Government

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.

Topic brexit business-strategies strategy

Medtech Insight: 世界の医療機器・医療技術の最新情報

UK To Demand 'Responsible Person' Be Physically Located In Country Under No-Deal Brexit

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: 世界の医療機器・医療技術の最新情報

EU Regulatory Roundup November 2018

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.

Topic Brexit Medtech

Pink Sheet:世界の薬事規制と承認審査に関するニュース

The Tricky Task Of Bringing Smaller EU Countries Into The Fold

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.

Topic brexit drug-development-landscape drug-approval

Pink Sheet:世界の薬事規制と承認審査に関するニュース

Brexit Likely To Force Refocusing Of Ambitious EU Network Strategy

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:世界の薬事規制と承認審査に関するニュース

Big Data In Medicines Regulation Will Need ‘Considerable Change In Mindset’

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:世界の医療機器に特化したニュース配信

Notified Body Capacity: TEAM-NB Members Way Ahead But Picture Clouded By Brexit

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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