Innovations In IDMP Preparation: Perspectives from Sponsors

September, 2020

Adapted from the Phlexglobal Innovation Tour virtual panel discussion, “Innovation on IDMP / Data Preparation,” held ...

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AI Powered Automation Proven in Life Sciences

April, 2020

Adapted from a March 25, 2020 Phlexglobal webinar, “How Automation is Transforming Regulatory Compliance in Life ...

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Prepare yourself for 2020 – Global regulatory update

December, 2019

With an ever-increasing regulatory landscape, it is important to know what is coming next. Looking into regulatory ...

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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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