DIA CMC Workshop

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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

James Pound

Interim Executive Director, Innovation and Compliance, Medicines and Healthcare products Regulatory Agency (MHRA), United Kingdom

Mihaela Buda, PHD

Scientific Programme Manager, European Pharmacopoeia Department, European Directorate for the Quality of Medicines & HealthCare (EDQM), France

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