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Session 7B: Biologics: Monographs and Standardisation
Session Chair(s)
Paul Varley, PHD
Vice President, Biopharmaceutical Development (Cambridge) Site Lead, MedImmune Ltd., United Kingdom
The question of how standardisation and Pharmacopoeial monographs can be used to ensure the quality of biological medicines remains a complex and challenging one. This session will aim to review this progress and discuss future challenges in this area.
Speaker(s)
Lionel Randon
Head of GRA CMC Regulatory Intelligence & Ops, Merck Serono, Switzerland
Industry View of Pharmacopoeial Monographs and Standardisation
James Pound
Interim Executive Director, Innovation and Compliance, Medicines and Healthcare products Regulatory Agency (MHRA), United Kingdom
MHRA Perspectives on Pharmacopoeial Standards for Biological Medicines
Mihaela Buda, PHD
Scientific Programme Manager, European Pharmacopoeia Department, European Directorate for the Quality of Medicines & HealthCare (EDQM), France
European Pharmacopoeia Texts for Biotherapeutic Products