What is a risk?

03.08.2020

Question of the Week

Definition of ICH Q9: The combination of the probability of occurrence of harm and the severity of that harm.

[GMP Compliance Adviser, Chapter 19.A]

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24.11.2025

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How is a QRM process initiated?

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FDA: Updated Pre-RFD Guidance for Combination Products

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EDQM: 9 Virtual Training Modules on Ph. Eur. and CEPs

The EDQM has introduced a modular training programme covering chemically defined active substances and medicinal products. It will take place between 1 and 12 December 2025.