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…
READ
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…
READ
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…
READ
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…
READ
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,…
READ
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…
READ
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…
READ
New Guideline on Specific Adverse Reaction Follow-up Questionnaires
The new draft guideline on Specific Adverse Reaction Follow-up Questionnaires (AR FUQs) is open for public consultation until February 9th,…
READ
CLINICAL TRIALS – transition of clinical trials in the Clinical Trials Information System (CTIS)
Clinical trials authorized under Directive 2001/20/EC (CTD) that are still ongoing after January 30th, 2025 will have to migrate…
READ
Implementation of International Recognition Procedure by MHRA
The ECDRP (EC Decision Reliance Procedure) is coming to an end on the 31st December 2023 and will be replaced…
READ