BREXIT: HOW DOES THIS PHENOMENON AFFECT MARKETING AUTHORIZATIONS IN ITALY?

It is now well-known that, following the Withdrawal Agreement between the United Kingdom and the European Union, the United Kingdom…

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DRUG DEVELOPMENT OPTIMIZATION USING MODELLING METHODOLOGY

Modeling and simulation are a proven scientific approach used to inform crucial drug development decisions. Specifically, scientists from the FDA…

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MARKET ACCESS – NEW GUIDELINES ON PRICING AND REIMBURSEMENT DOSSIERS OF MEDICINAL PRODUCTS

With Resolution no. 1372/2020, published on its institutional website on 30/12/2020, AIFA has adopted the consolidated version of the new…

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MEDICAL DEVICES – UK MEDICAL DEVICE REGULATION 2002 – HOW TO PLACE MEDICAL DEVICES IN THE UK MARKET AFTER THE BREXIT GRACE PERIOD END

No deal-Brexit grace period end is now upon us and starting from 1st January 2021 all the manufacturers wishing to…

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GUIDANCE ON THE MANAGEMENT OF CLINICAL TRIALS DURING THE COVID-19 PANDEMIC

The impact of the COVID-19 pandemic on health systems and more broadly on society, make it necessary for sponsors to…

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LEGISLATIVE DECREE 3 SEPTEMBER 2020, N. 116

The Italian authority has recently issued the LEGISLATIVE DECREE 3 September 2020, n. 116 Implementation of directive (EU) 2018/851 amending…

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MEDICAL DEVICES – EUROPEAN REGULATION 2017/745 – ROUTE TO EUDAMED: THE NEW ACTOR REGISTRATION MODULE ACTIVE SOON

EUDAMED is the IT system developed by the European Commission to implement Regulation (EU) 2017/745 on medical devices and Regulation…

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REGULATORY AFFAIRS – NEW PLATFORM FOR SCIENTIFIC ADVICE

Starting from October 19th, 2020, developers of human medicines should use the European Medicines Agency (EMA)’s IRIS Regulatory & Scientific…

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MARKET ACCESS – NEW DRAFT GUIDELINES ON PRICING AND REIMBURSEMENT DOSSIERS OF MEDICINAL PRODUCTS

Following the publication of the new Decree relevant to the negotiation of Price and Reimbursement of medicinal products (Decree 2nd…

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MARKET ACCESS – NEW ITALIAN DECREE ON THE PROCEDURES FOR PRICING AND REIMBURSEMENT OF MEDICINAL PRODUCTS PUBLISHED IN THE ITALIAN OFFICIAL JOURNAL

After almost a year of waiting, the new Decree from the Italian Ministry of Health and the Ministry of Economy…

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