Industry news

NSF Health Sciences experts bring you the latest news updates from the industry

Critical Decisions in Medical Devices

Thursday the 10th April 2014

The medical device industry faces dramatic changes in the way it is regulated, particularly in Europe. James Pink, Vice President Europe of NSF Health Sciences, discusses the challenges facing the quality professional.

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As featured in the April issue of Quality W...

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New EU Clinical Trial Regulation approved by the European Parliament

Wednesday the 9th April 2014

On 2 April 2014 the text of the new CT Regulation, which will replace the CT Directive 2001/20/EC, was approved by the European Parliament. The regulation is expected to be published in the Official Journal by mid-2014 and become effective in mid-2016.

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European Medicines Agency Launches Adaptive Licensing Pilot Project

Wednesday the 26th March 2014

To improve timely patient access to new medicines, the European Medicines Agency (EMA) launched a pilot project that employs an adaptive licensing approach to real medicines in development.

Adaptive licensing, sometimes called staggered approval or progressive licensing, is a prospectively pla...

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CDSCO (India) Announced That Imported Drug Products Must Meet Indian Medicinal Products Requirements

Tuesday the 18th March 2014

The Indian drug regulatory agency Central Drugs Standard Control Organization (CDSCO) announced on March 4 that drug products imported into India must comply with Indian requirements for the manufacture of medicinal products.

CDSCO has increased surveillance of medical products imported into I...

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How to cope with an unprecedented level of change?

Wednesday the 5th March 2014

The pharmaceutical industry is facing a blizzard of new legislation and guidance. How can quality professionals and their senior management cope with this? Are senior management even aware of much of this change? Some of the changes (ICH Q10, EU GMP Chapters 1 and 2) make it very clear that ulti...

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A word from NSF Health Sciences

The legislation and guidance that apply to the healthcare industries is forever changing. NSF Health Sciences will provide you with regular updates on what is new and will also provide you with expert interpretation of these changes - what they mean

Peter Gough

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