NEW EUDRAVIGILANCE VERSION: IMPACT ON THE ITALIAN PV SYSTEM

On November 22nd, 2017 EMA will launch a new and improved version of EudraVigilance. This will have impact also to…

READ

REGULATORY PHARMA NET EXHIBITS AT ISPOR 20TH Annual European Congress

RPN will exhibit at ISPOR 20TH Annual European Congress that will be held at the Scottish Event Campus (SEC), Glasgow, Scotland  4-8…

READ

Make or buy? Regulatory, Pharmacovigilance and Market Access Outsourcing

Pharmaceutical company resources continue to decrease, regulatory rules have become stricter and complex such as approval processes and post-approval requirements….

READ

BREXIT IMPACT ON PHARMACEUTICALS

It is about one year, from the date of the outcome of the Brexit referendum, that Pharmaceutical Companies are trying…

READ

NEW REGULATIONS ON MEDICAL DEVICES AND IN-VITRO DIAGNOSTIC MEDICAL DEVICES

The new Regulations on medical devices and in-vitro diagnostic medical devices were published in the Official Journal of the European…

READ

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…

READ

Pharmacovigilance: literature monitoring

The worldwide literature monitoring is a regulatory requirement for all the Marketing Authorisation Holders (MAHs) and it should be performed…

READ

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…

READ

NEW 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…

READ

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)…

READ