The International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH)

International regulation: the importance of quality assurance in drug development

4 July 2023 | By Raquera Brown (Zymeworks)

Raquera Brown, Executive Director of Quality at Zymeworks offers quality and compliance professionals advice on how to navigate the often-complex regulatory space during development of innovative drugs like antibody therapeutics.

news

EMA publishes updated Q&A for ICH M10

26 January 2023 | By Catherine Eckford (European Pharmaceutical Review)

An updated Q&A document for ICH M10 'Bioanalytical Method Validation and Study Sample Analysis’ has been published by the European Medicines Agency (EMA).

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Recommended

The International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH)

International regulation: the importance of quality assurance in drug development

EMA publishes updated Q&A for ICH M10