How New EU Regulations Will Impact Regulation of Medical Devices

May, 2019

The adoption of Regulation (EU) 2017/745 on Medical Devices (MDR) and Regulation (EU) 2017/746 on In-Vitro Diagnostic ...

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SPOR Update 2018 – News from the EMA webinar

March, 2018

The implementation process of SPOR over several phases… that’s nothing new. However, after the 6-month delay due to the ...

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The Challenge with EMA’s Changing Timelines for IDMP

July, 2017

A combination of factors has resulted in the shifting timeline of EMA’s implementation of the IDMP data collection. One ...

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Regulatory Information Management - the Compliance & Efficiency Union

June, 2017

While the opinions about the information model for Regulatory Information Management vary and are subject to many ...

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IDMP Update

March, 2017

News and updates from the SPOR Task Force Meeting held on 10 March 2017. As previously communicated, OMS and RMS UAT ...

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Cloud adoption within Life Sciences and Pharma Industries is growing

January, 2017

Gartner, the world’s leading information technology research and advisory company, predicts that IT spending in the ...

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SPOR – Key Activities For The Industry (EMA-Update)

August, 2016

On August 4, 2016, The European Medicines Agency (EMA) hosted a webinar for the industry to further the understanding ...

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