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….

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BREXIT IMPACT ON PHARMACEUTICALS

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

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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…

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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…

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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…

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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)…

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THE 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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