EDQM's Training on European Pharmacopoeia
European Pharmacopoeia Training, organized by the European Directorate for the Quality of Medicines & HealthCare (EDQM), will be held in Zagreb from 24 to 25 May 2018.
The purpose of the training is to enable participants to expand their existing knowledge and to familiarize them with the work of the European Pharmacopoeia, with an emphasis on review of the European regulatory framework and the role of the European Pharmacopoeia at European and international level, including international harmonization activities. Practical advice on the use and interpretation of the General Chapters and Monographs, as well as the methods by which they are elaborated and revised, will also include an introduction to the processes of establishing European Pharmacopoeia Reference Standards. Along with a review of the regulatory requirements for a Certificate of Suitability (CEP) for monographs, lectures will include guidance and advice on the preparation of a successful dossier.
This training is intended for national regulatory bodies, manufacturers, and managers from quality control and regulatory affairs.