CLINICAL TRIALS – CALL AIFA 2018 FOR INDEPENDENT RESEARCH ON MEDICINAL PRODUCTS
The Italian Medicines Agency (AIFA) has recently published a call for independent research focused on three thematic areas considered of…
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SCIENTIFIC SERVICE IN ITALY: FROM THE PAST TO THE FUTURE
Since 1 July 1993 with the Legislative decree 30 December 1992, n. 541 and after its abolition following the entry…
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IMPACTS AND NEWS OF THE FINANCIAL LAW 2019
Within the publications of the annual Financial Law, some new depositions have been set for the healthcare system and the…
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EUROPEAN REGULATION 2017/745 – NEW DEFINITION OF INCIDENT AND UPDATES ON VIGILANCE AND POST-MARKET SURVEILLANCE ACTIVITIES
The new European Regulation 2017/745 on medical devices will introduce new activities and a new approach in the management of…
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THE MAIN INNOVATIONS OF THE EUROPEAN REGULATION 745/2017
In about one year the new European regulation on medical devices, European Regulation 745/2017, will be reality and the new…
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EUROPEAN REGULATION 2017/745 – Clinical evaluation: new requirements for equivalence demonstration
The European regulation 2017/745, that will entry into force in May 2020, introduces several new elements with an impact on…
READ“Pharma disclosure”: EFPIA’s Code on Transfers of Value
Starting from 2016, European Federation of Pharmaceutical Industries and Associations (EFPIA) member companies made public the details of payments and…
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MEDICAL DEVICES – European Regulation 2017/745 – What happens to CE certificates obtained in compliance with the “old directive” 93/42/EEC?
The entry into force of the new regulation is now close. From 26 May 2020 it will no longer be…
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The management of the clinical trial in Italy after the Brexit
On 29 March 2017 The United Kingdom notified its intention to withdraw from the European Union. Thus, unless there…
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Optimising Orphan Drug Development in the EU
The legislative framework on orphan medicinal products aims at stimulating research and development of medicinal products for rare diseases…
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