ACT EU: Launch of Two New Pilot Projects for Scientific Advice and Clinical Trials in Europe
The Accelerating Clinical Trials in the EU (ACT EU) initiative has launched two pilot projects aimed at improving the quality…
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Certificate of Pharmaceutical Product as strategic plan for Extra – EU market: how to request it to AIFA.
The Certificate of Pharmaceutical Product (CPP) is a document issued by a country’s regulatory authority at the request of a…
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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…
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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…
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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…
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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…
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EMA’S NEW GUIDELINES ON ENVIRONMENTAL RISK ASSESSMENT FOR HUMAN MEDICINAL PRODUCTS
The European Medicines Agency (EMA) has recently published a significant update to its guideline on Environmental Risk Assessment (ERA) for…
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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)…
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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…
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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…
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