This international conference brought together representatives from European and national authorities, Chairs and members of European Pharmacopoeia (Ph. Eur.) groups, regulators, industry, trade associations as well as other key stakeholders from around the world.
The two-day conference included two plenary sessions and four workshops on:
- Setting pharmacopoeial standards for biotherapeutic products;
- New technologies and their potential impact on monographs;
- The control of elemental impurities;
- International harmonisation.
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Target audience
This conference is of interest to those persons involved in the quality of medicines, be it in R&D, manufacturing (APIs or excipients), regulatory affairs, quality control, quality assurance or similar functions, and to those working in regulatory agencies and health ministries.
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- Plenary Day 1 : The EDQM in the context of the European regulatory framework
- Workshop – Setting Pharmacopoeial Standards for Biotherapeutic Products – afternoon
- Workshop – Setting Pharmacopoeial Standards for Biotherapeutic Products – morning
- Workshop – Control of Elemental Impurities
- Workshop – New technologies
- Workshop – Excipients Other Components and International Harmonisation
- Closing Plenary Day 2
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