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36 Total results for product and free and sample content found

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

Scrip:世界の医薬品産業ニュースサービス

Sanofi Top UK Exec Plans For Hard Brexit, Blasts 'Poor Access' To New Drugs

By sten-stovall 22 Aug 2018

The managing director for Sanofi in the UK says clinical trials there will become less likely in future if access to innovative drugs doesn't improve, causing comparative standards of care to deteriorate.

Topic brexit business-strategies clinical-trials

Scrip:世界の医薬品産業ニュースサービス

Pharma Backs UK Parliament Report As 'No Deal Brexit' Fears Grow

22 Aug 2018

The pharmaceutical sector has given its backing to a report from MPs which warns that a no-deal Brexit will have a hugely damaging effect on the industry in the country, turning it into "a second-tier state for new and innovative medicines."

Topic brexit business-strategies

Medtech Insight:世界の医療機器に特化したニュース配信

New Reasons Not To Use EU MDR's Four-Year Extension, But Comply Earlier Or Retire Products Instead

22 Aug 2018

The new EU Medical Device Regulation offers companies an option to market CE-marked devices for an extra four years under current directives. But more hurdles are being identified that make this option less attractive.

Topic brexit business-strategies

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