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50 YEARS OF EDQM: PREPARING FOR THE FUTURE TO CONTINUOUSLY ENSURE THE QUALITY OF MEDICINES
Session Chair(s)
Susanne Keitel, DrSc, RPh
Director
European Directorate for the Quality of Medicines & Healthcare (EDQM), France
The European Directorate for the Quality of Medicines and HealthCare (EDQM) turned 50 in 2014. While EDQM and its 37 Member States are proud of the tremendous achievements over the past 50 years, globalisation and technical and scientific developments in all fields pose constant challenges. The session will provide an insight to EDQM’s activities, and focus on current hot topics such as the introduction of finished product monographs in the European Pharmacopoeia, the impact of Quality by Design (QbD), recent developments in pharmacopoeial harmonisation, the holistic strategy in combating counterfeit medicines and the establishment of a harmonised European paediatric formulary of unlicensed medicines..
Speaker(s)
Finished Product Monographs and Current “Hot Topics” of the European Pharmacopoeia
Cathie Vielle, PharmD
EDQM/Council of Europe, France
Head of the European Pharmacopoeia Department
QbD and the Pharmacopoeia
Graham Cook, PhD
Pfizer Global Quality Intelligence and Compendial Affairs, United Kingdom
Senior Director
An Update on Pharmacopoeial Harmonisation
Susanne Keitel, DrSc, RPh
European Directorate for the Quality of Medicines & Healthcare (EDQM), France
Director
The EDQM’s Holistic Anti-Counterfeiting Strategy
Francois Lery, PharmD, PhD
WHO, France
Coordinator for Technologies, Standards and Norms
“Paedform” – A Harmonised European Paediatric Formulary
Dirk Leutner, PhD
EDQM/Council of Europe, France
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