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

  The Italian Medicines Agency (AIFA) recently introduced a guideline for Notified Bodies planning to submit a consultation for ancillary…

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Navigating the Transition: The Evolution of Regulatory Procedure Management in Product Lifecycle Management towards IRIS

The landscape of Product Lifecycle Management (PLM) is undergoing a significant transformation, especially in the realm of Regulatory Procedure Management…

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Sunshine Act: Promoting Transparency in the Italian Healthcare landscape

The Italian healthcare landscape has undergone a significant turning point with the enforcement of Law No. 62 of May 31,…

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Updates on the new AIFA Regulation: CSE and reorganisation

The long-awaited, new regulation on the organization and functioning of the Italian Medicines Agency (AIFA) was published in the Italian…

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Vigilance system for CE-marked medical devices: insights from the new MDCG 2024-1

The MDCG 2024-1 – Guidance on the vigilance system for CE-marked devices document, recently endorsed by the Medical Device Coordination…

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