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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)
Industry View of Pharmacopoeial Monographs and Standardisation
Lionel Randon
Merck Serono, Switzerland
Head of GRA CMC Regulatory Intelligence & Ops
MHRA Perspectives on Pharmacopoeial Standards for Biological Medicines
James Pound
Medicines and Healthcare products Regulatory Agency (MHRA), United Kingdom
Group Manager - British Pharmacopoeia & Laboratory Services
European Pharmacopoeia Texts for Biotherapeutic Products
Mihaela Buda, PhD
European Directorate for the Quality of Medicines & HealthCare (EDQM), France
Scientific Programme Manager, European Pharmacopoeia Department