Sunshine Act: Promoting Transparency in the Italian Healthcare landscape
Regulatory Pharma Net Blog
by Margherita Rainò
5d ago
The Italian healthcare landscape has undergone a significant turning point with the enforcement of Law No. 62 of May 31,... L'articolo Sunshine Act: Promoting Transparency in the Italian Healthcare landscape sembra essere il primo su - RPN ..read more
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Updates on the new AIFA Regulation: CSE and reorganisation
Regulatory Pharma Net Blog
by Claudia Garimberti
1w ago
The long-awaited, new regulation on the organization and functioning of the Italian Medicines Agency (AIFA) was published in the Italian... L'articolo Updates on the new AIFA Regulation: CSE and reorganisation sembra essere il primo su - RPN ..read more
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CLINICAL TRIALS – transition of clinical trials in the Clinical Trials Information System (CTIS)
Regulatory Pharma Net Blog
by Francesca Spera
2M ago
  Clinical trials authorized under Directive 2001/20/EC (CTD) that are still ongoing after January 30th, 2025 will have to migrate... L'articolo CLINICAL TRIALS – transition of clinical trials in the Clinical Trials Information System (CTIS) sembra essere il primo su - RPN ..read more
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Implementation of International Recognition Procedure by MHRA
Regulatory Pharma Net Blog
by Debora Gallorini
2M ago
The ECDRP (EC Decision Reliance Procedure) is coming to an end on the 31st December 2023 and will be replaced... L'articolo Implementation of International Recognition Procedure by MHRA sembra essere il primo su - RPN ..read more
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New AIFA Regulation: where are we?
Regulatory Pharma Net Blog
by Claudia Garimberti
2M ago
Almost one year after the publication of the relevant law, the long-awaited reorganisation of the Italian Medicines Agency (AIFA) seems... L'articolo New AIFA Regulation: where are we? sembra essere il primo su - RPN ..read more
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PERIODIC SAFETY UPDATE REPORTS (PSURs) ACCORDING TO REGULATION (EU) 2017/745 (MDR)
Regulatory Pharma Net Blog
by Riccardo Chiarini
3M ago
The MDR requires manufacturers of class IIa, class IIb, and class III devices to prepare and submit a Periodic Safety... L'articolo PERIODIC SAFETY UPDATE REPORTS (PSURs) ACCORDING TO REGULATION (EU) 2017/745 (MDR) sembra essere il primo su - RPN ..read more
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The Revolutionary Role of Artificial Intelligence in Medical Devices
Regulatory Pharma Net Blog
by Miriam Di Fonzo
5M ago
Artificial Intelligence (AI) has been a true revolution in many sectors, but perhaps one of the most promising is that... L'articolo The Revolutionary Role of Artificial Intelligence in Medical Devices sembra essere il primo su - RPN ..read more
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BILINGUALISM REQUIREMENT FOR MEDICINES IN THE PROVINCE OF BOLZANO AND POSSIBLE EXEMPTIONS
Regulatory Pharma Net Blog
by Valentina Ciurlia
5M ago
The Italian Decree n. 219/2006 (implementing 2001/83/EC Directive and following amendments) establishes that at least the information reported in the... L'articolo BILINGUALISM REQUIREMENT FOR MEDICINES IN THE PROVINCE OF BOLZANO AND POSSIBLE EXEMPTIONS sembra essere il primo su - RPN ..read more
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AIFA REPORT ON TIMELINES FOR PRICING AND REIMBURSEMENT PROCEDURES IN THE PERIOD 2018-2022
Regulatory Pharma Net Blog
by Carolina Moreno
5M ago
On 27 April 2023, the Italian Medicines Agency (AIFA) published a report on the timelines of “Pricing and Reimbursement” procedures... L'articolo AIFA REPORT ON TIMELINES FOR PRICING AND REIMBURSEMENT PROCEDURES IN THE PERIOD 2018-2022 sembra essere il primo su - RPN ..read more
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SCIENTIFIC ADVICE TO MANUFACTURERS OF HIGH-RISK MEDICAL DEVICES
Regulatory Pharma Net Blog
by Miriam Di Fonzo
5M ago
EMA has launched a pilot to give scientific advice on the intended clinical development strategy and proposals for clinical investigation for all... L'articolo SCIENTIFIC ADVICE TO MANUFACTURERS OF HIGH-RISK MEDICAL DEVICES sembra essere il primo su - RPN ..read more
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