EUROPEAN MEDICINES AGENCY - PIC/S Quality Risk Management Expert Circle on ICH Q9(R1)

This is a recording of a training course held at EMA on 28 - 30 January 2025. Its aim was to support GMP inspectors in evaluating the implementation and use of risk assessment and Quality Risk Management by manufacturers, in line with the updated ICH Q9(R1) guideline

date: 20/05/2025

Topics: Five main topic areas addressed in the 2023 revision of the ICH Q9 guideline:

Subjectivity in QRM
Product Availability Risks
Formality in QRM
Risk-based Decision-making
Hazard Identification.

A 6th topic, Risk Review, was also addressed in the training materials that support ICH Q9(R1) and therefore covered by this course despite the fact that no new guidance is provided in the guideline.

Target audience: Senior GMP and GDP inspectors

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Link for EMA

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