Étiqueté : Quality documentation

ICH Q9(R1) implementation working group updated training materials (from Catapult’s regulatory round-up for November 2024)

ICH has announced the publication of the updated training materials related to ICH Q9(R1) Quality Risk Management (QRM). These materials, include a Q9(R1) Introduction Presentation replacing five presentations in the current ICH Q9 Briefing Pack...

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Guideline on the requirements for quality documentation concerning biological investigational medicinal products in clinical trials

The guideline addresses the specific documentation requirements on the biological, chemical and pharmaceutical quality of IMPs containing biological / biotechnology derived substances. Read the news announcement published by the European Commission on 14 February 2022.

Étiqueté : Quality documentation

ICH Q9(R1) implementation working group updated training materials (from Catapult’s regulatory round-up for November 2024)

Guideline on the requirements for quality documentation concerning biological investigational medicinal products in clinical trials

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Étiqueté : Quality documentation

ICH Q9(R1) implementation working group updated training materials (from Catapult’s regulatory round-up for November 2024)

Guideline on the requirements for quality documentation concerning biological investigational medicinal products in clinical trials

About ELSIBI

Contact us

MENU

Catégories

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