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PHARMACOPOEIAL HARMONISATION- A NEVER ENDING STORY
Session Chair(s)
Susanne Keitel, DrSc, RPh
Director
European Directorate for the Quality of Medicines & Healthcare (EDQM), France
The need to harmonise pharmacopoeial requirements in a globalised world has already been identified in the late 80s. However, the outcome of the Pharmacopoeial Discussion Group, an informal harmonisation initiative set up by three major pharmacopoeias, has yet to meet the pharmacopoeias’ and stakeholders’ expectation. The session will provide an update on industry needs, current harmonisation initiatives and the approaches taken, and will offer a platform for open discussion with the panel of speakers.
Speaker(s)
Pharmacopoeial Harmonisation – Stakeholder expectations
Neil Schwarzwalder
Eli Lilly and Company, United States
Quality Consultant Compendial Affairs
Current Global Pharmacopoeia Activities
Sabine Kopp, PhD
World Health Organization (WHO), Switzerland
Group Lead, Medicines Quality Assurance
Regional and PDG Activities
Susanne Keitel, DrSc, RPh
European Directorate for the Quality of Medicines & Healthcare (EDQM), France
Director
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