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Jun, 27 2019

ASSENT-BY-DEFAULT PROCEDURE UPDATE

With the new disposition DG/512/2019 of 12 March 2019, AIFA has updated the application of the assent-by-default procedure, in for...

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Jun, 27 2019

ITALY TOWARDS THE IMPLEMENTATION OF THE NE...

In view of the new European legislation (EU Regulation 536/2014) about the clinical trial, the Law No. 3 of 11 January 2018 (so-ca...

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Jun, 18 2019

MEDICAL DEVICES – European Regulation 20...

The new European Regulation 2017/745 will introduce a new clinical document: the “summary of safety and clinical performance”....

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RPN @regulatorypharmanet - JUN 4

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