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Nov, 07 2022

EMA DRAFTS RECOMMENDATIONS ON IDENTIFYING ...

Real world data (RWD) describe the experience of patients through data collected in surveys, registries, and more recently from se...

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Nov, 04 2022

CLINICAL TRIALS – EVALUATION OF A CLINIC...

According to the Regulation (EU) no. 536/2014, the evaluation of a clinical trial application in CTIS includes three main steps: ...

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Oct, 20 2022

USABILITY ASSESSMENT OF MEDICAL DEVICES AN...

The Regulations (EU) 2017/745 (MDR) and 2017/746 (IVDR) require the demonstration of compliance with the General Safety and Perfo...

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RPN @regulatorypharmanet - JUN 4

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