REGULATORY PHARMA NET EXHIBITS AT DIA EUROMEETING | 29-31 March 2017, GLASGOW – UNITED KINGDOM
RPN will exhibit at DIA EuroMeeting which will be held in Glasgow. You are warmly welcome to visit our booth…
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Pharmacovigilance: literature monitoring
The worldwide literature monitoring is a regulatory requirement for all the Marketing Authorisation Holders (MAHs) and it should be performed…
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Clinical Evaluation of Medical Devices
Clinical evaluation is the analysis and evaluation of clinical data pertaining to a medical device, in order to verify the…
READNEW PERSPECTIVE ON QUALITY ASSESSMENT: ELEMENTAL IMPURITIES
In accordance with ICH Q3D (EMA/CHMP/ICH/353369/2013), a process to assess and control elemental impurities in the drug product, developing a…
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Pilot Voluntary Harmonisation Procedure project for the joint assessment of Clinical Trial Applications by AIFA and the Ethics Committees in Italy
The Voluntary Harmonisation Procedure (VHP) is a harmonised procedure for assessing multinational clinical trials (involving 2 or more member states)…
READTHE LINGUISTIC REVIEW PROCESS OF PRODUCT INFORMATION FOR CENTRALLY AUTHORISED MEDICINAL PRODUCTS
To ensure high quality and consistent Product Information (PI) of centrally authorised medicinal products in the Member States of the…
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EMA’s PRIME scheme: early dialogue on PRIority MEdicines for the patients
On 1st June 2016 the European Medicines Agency (EMA) released the outcome of the assessment of the first group of…
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RECALL PROCEDURE IN ITALY
When a recall procedure is required due to quality product defects, the Company GMP Qualified Person must inform immediately AIFA…
READREGULATORY PHARMA NET EXHIBITS AT DIA EUROMEETING 6-8 APRIL 2016, HAMBURG, GERMANY
RPN will exhibit at DIA EuroMeeting which will be held in Hamburg. You are warmly welcome to visit our booth…
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UNIFARM DATABASE FOR THE FULFILLMENT OF THE BILINGUAL REQUIREMENT IN THE ITALIAN PROVINCE OF BOLZANO
According to the Italian Decree n. 219/2006 (implementing 2001/83/EC Directive and following amendments), at least the information reported in the…
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