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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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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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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According to GVP (Good Pharmacovigilance Practices) Module VI, MAHs are required to conduct actively global literature searches at least once…
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The Italian Medicines Agency (AIFA) recently introduced a guideline for Notified Bodies planning to submit a consultation for ancillary…
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The landscape of Product Lifecycle Management (PLM) is undergoing a significant transformation, especially in the realm of Regulatory Procedure Management…
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The Italian healthcare landscape has undergone a significant turning point with the enforcement of Law No. 62 of May 31,…
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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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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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The new draft guideline on Specific Adverse Reaction Follow-up Questionnaires (AR FUQs) is open for public consultation until February 9th,…
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Clinical trials authorized under Directive 2001/20/EC (CTD) that are still ongoing after January 30th, 2025 will have to migrate…
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