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Apr, 15 2024

Transitioning to CTIS: Key Steps and Docum...

The transition of clinical trial applications from the Directive 2001/20/EC (CTD) to the Regulation EU No 536/2014 (CTR), facilita...

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Apr, 08 2024

Clarifying “Day Zero” in Medical Liter...

According to GVP (Good Pharmacovigilance Practices) Module VI, MAHs are required to conduct actively global literature searches at...

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Mar, 26 2024

AIFA’s New Guidelines for Class III ...

  The Italian Medicines Agency (AIFA) recently introduced a guideline for Notified Bodies planning to submit a consultatio...

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RPN @regulatorypharmanet - JUN 4

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