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XVII Congresso Nazionale Sihta 2024

COMUNICARE LA CONOSCENZA HTA, l’agire consapevole Sono due gli elementi cruciali per la HTA e i processi di decisione informata:... L'articolo XVII Congresso Nazionale Sihta 2024 sembra essere il primo...

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CPHI Milan

  CPHI Milan (or CPHI Worldwide) is one of the largest and most important international trade fairs dedicated to the... L'articolo CPHI Milan sembra essere il primo su - RPN.

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XLV CONGRESSO NAZIONALE SIFO

XLV CONGRESSO NAZIONALE SIFO Next Generation Pharmacy: Missione, Visione e Valore 17-20 ottobre, Mostra D’Oltremare Napoli   Razionale   Il... L'articolo XLV CONGRESSO NAZIONALE SIFO sembra essere il...

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Medical Devices – EMA Launches Pilot Program to Support Orphan Devices

The European Medicines Agency (EMA) has launched a groundbreaking pilot program designed to enhance the development and regulatory support for... L'articolo Medical Devices – EMA Launches Pilot Program...

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Updated Guidelines for the Classification and Conduct of Observational...

The Italian Medicines Agency (AIFA) has published a comprehensive update to the guidelines for the classification and conduct of observational... L'articolo Updated Guidelines for the Classification...

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EMA – New Fee Regulation (NFR)

The European Medicines Agency (EMA) has officially announced that starting from 1st January 2025, the current fee regulation (2024/568) will... L'articolo EMA – New Fee Regulation (NFR) sembra essere...

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Understanding the European HTA Regulation

Introduction to HTA Regulation The Health Technology Assessment (HTA) Regulation (2021/2282) represents a significant milestone towards a unified approach in... L'articolo Understanding the European...

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ACT EU: Launch of Two New Pilot Projects for Scientific Advice and Clinical...

The Accelerating Clinical Trials in the EU (ACT EU) initiative has launched two pilot projects aimed at improving the quality... L'articolo ACT EU: Launch of Two New Pilot Projects for Scientific...

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Certificate of Pharmaceutical Product as strategic plan for Extra – EU...

The Certificate of Pharmaceutical Product (CPP) is a document issued by a country’s regulatory authority at the request of a... L'articolo Certificate of Pharmaceutical Product as strategic plan for...

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Clinical Trials – CCNCE Report on Ethical Committees

The National Coordination Center for Ethical Committees (CCNCE) report highlights critical issues and recommendations for Italy’s 40 Territorial Ethical Committees... L'articolo Clinical Trials – CCNCE...

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The Impact of AI on Pharmaceutical Regulatory Processes

Over the past few years, the use of Artificial Intelligence (AI) in pharmaceutical industry is rapidly expanding. AI is a... L'articolo The Impact of AI on Pharmaceutical Regulatory Processes sembra...

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Italian Medical Devices Database: Important Updates for Legacy Devices

Legacy devices are those that were approved under the previous MDD but are still in use or available on the... L'articolo Italian Medical Devices Database: Important Updates for Legacy Devices sembra...

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Transparency in Healthcare domain: Transfers of value

The transparency of transfers of value declared by pharmaceutical companies is crucial for maintaining trust and integrity within the healthcare... L'articolo Transparency in Healthcare domain:...

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EMA’S NEW GUIDELINES ON ENVIRONMENTAL RISK ASSESSMENT FOR HUMAN MEDICINAL...

The European Medicines Agency (EMA) has recently published a significant update to its guideline on Environmental Risk Assessment (ERA) for... L'articolo EMA’S NEW GUIDELINES ON ENVIRONMENTAL RISK...

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The regulation of the Scientific-Economic Commission of Pharmaceuticals of AIFA

The regulation detailing the organization and functioning of the Scientific-Economic Commission of Pharmaceuticals (CSE) of the Italian Medicines Agency (AIFA)... L'articolo The regulation of the...

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3° CONGRESSO NAZIONALE GIRF – GRUPPO ISPOR ROMA FOR FUTURE

RAZIONALE ISPOR Italy Rome Chapter, in qualità di Società Scientifica formata da membri multistakeholder che opera a livello nazionale nel... L'articolo 3° CONGRESSO NAZIONALE GIRF – GRUPPO ISPOR ROMA...

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63° SIMPOSIO AFI Le Sfide dell’Industria della Salute: Ricerca, Innovazione,...

Ricerca, Innovazione, Sostenibilità Il 63° Simposio AFI si terrà dal 5 al 7 Giugno 2024 al Palacongressi di Rimini. Le tematiche... L'articolo 63° SIMPOSIO AFI Le Sfide dell’Industria della Salute:...

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Transitioning to CTIS: Key Steps and Documentation Required

The transition of clinical trial applications from the Directive 2001/20/EC (CTD) to the Regulation EU No 536/2014 (CTR), facilitated by... L'articolo Transitioning to CTIS: Key Steps and Documentation...

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Clarifying “Day Zero” in Medical Literature Reporting: focus on paper journals.

According to GVP (Good Pharmacovigilance Practices) Module VI, MAHs are required to conduct actively global literature searches at least once... L'articolo Clarifying “Day Zero” in Medical Literature...

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AIFA’s New Guidelines for Class III Medical Devices with Ancillary Medicinal...

  The Italian Medicines Agency (AIFA) recently introduced a guideline for Notified Bodies planning to submit a consultation for ancillary... L'articolo AIFA’s New Guidelines for Class III Medical...

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