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Session 5 / Venue 6: Pharmacopoeia and Biologics
Session Chair(s)
Teruhide Yamaguchi, PhD
Office of Cellular and Tissue-based Products
Pharmaceuticals and Medical Devices Agency (PMDA), Japan
Pharmacopoeia is a set of pharmaceutical quality standards in the country. The major developed countries have own pharmacopoeia. In the European Union, the European pharmacopoeia (EP) is used among the member countries. On the other hand, Pharmacopoeial discussion group (PDG) has been working to harmonize monographs and general chapters since 1989 in order to correspond to the internationalization of pharmaceutical production and distribution. This session will focus on specific issues of biologics (e.g. monoclonal antibody and impurity control of protein preparation) which are expected to be internationally harmonized in the future. Each representative from JP (the Japanese Pharmacopoeia), EP and USP (the United States Pharmacopeia) will introduce the current situation and states of the biologics. The goal is to share the information from each pharmacopoeia and discuss the next challenges for the future.
Speaker(s)
Current situation and issues in Japanese Pharmacopoeia
Nana Kawasaki, PhD
National Institute of Health Sciences, Japan
Head, Division of Biological Chemistry and Biologicals
European Pharmacopoeia update in the field of biologicals
Emmanuelle Charton, PhD
European Directorate for the Quality of Medicines (EDQM), France
Deputy Head, European Pharmacopoeia Department
Biologic Standards – USP Perspective
Ranjan Chakrabarti, PhD
United States Pharmacopeia - India, India
Vice President, Biologics & Biotechnology Dept
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