About Sonia Monni

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So far Sonia Monni has created 174 blog entries.

MDR and information from the manufacturer: all the news

2022-03-04T15:11:54+01:0023 March 2021|Medical Devices Regulation|

With the entry into force of the MDR there are several areas that have been revised as they are treated more roughly in the old Directive, among these there are also the information supplied with the device: in order to present the correct use of your device , each manufacturer is in fact required to affix on labels, packaging and instructions for use, all the information necessary for its use, such as the risks and benefits, operating methods, CE mark, etc. Let's see the updates.

Collaboration between pharmacovigilance and quality: how to make it possible when the affiliates have different nature

2022-03-04T15:13:16+01:0018 February 2021|Pharmacovigilance|

During the AFI webinar "Pharmacovigilance and quality" on 27th November, Dr. Donata Saddemi and Dr. Barbara Belloni respectively Pharmacovigilance Manager & Regulatory Associate and QA Manager & Qualified Person of the pharmaceutical company Recipharm Italia, illustrated their complaint management flow.

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