The programme was designed to enable participants to expand their knowledge and familiarise themselves with the work and procedures of the European Pharmacopoeia and related activities of the EDQM.
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Target audience
This workshop is of interest to those interested or working in development, production, quality control and regulatory affairs.
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- EDQM and the European Pharmacopoeia: role in the European regulatory network by Susanne Keitel
- General Concepts in the European Pharmacopoeia by Cathie Vielle
- Specific monographs on substances for pharmaceutical use by Ulrich Rose
- Use of Reference Standards in specific monographs by Jochen Pauwels
- Impurity Control in the European Pharmacopoeia by Ulrich Rose
- Use of Reference Standards for impurity control by Jochen Pauwels
- Specific Monographs on Finished Products (containing chemically defined APIs) by Ulrich Rose
- Use of Reference Standards for Finished Products by Jochen Pauwels
- Role of RS in monographs for recombinant biotherapeutics – Peptide mapping and glycan analysis by Jochen Pauwels
- The Certification of Suitability (CEP) Procedure by Susanne Keitel
- Nitrosamine impurities in sartans: the EDQM holistic approach to address the issue by Susanne Keitel
- New and revised Ph. Eur. General Chapters by Ulrich Rose
- The Ph. Eur. enabling QbD and Continuous Manufacturing by Cathie Vielle
- How to participate in the Elaboration of the European Pharmacopoeia by Mihaela Buda
- International Harmonisation and Collaboration Initiatives by Cathie Vielle
- Find your way in Pharmeuropa – Knowledge database & Ph. Eur. Online: Useful hints and other practicalities by Pierre Leveau
- European Pharmacopoeia Reference Standards: Establishment by Jochen Pauwels
- European Pharmacopoeia Reference Standards: Handling, dispatch, where to find useful information and other practicalities by Pierre Leveau
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