Venue: Hotel Dubrovnik, Ljudevita Gaja 1, PP 246, 10000 Zagreb, Croatia
Working language: English
The programme has been designed to enable participants to expand their knowledge and familiarise themselves with the work and procedures of the European Pharmacopoeia.
The programme covers:
- An overview of the European regulatory framework, the role of the European Pharmacopoeia at a European and international level, including international harmonisation activities;
- Practical advice on using and interpreting the European Pharmacopoeia General Chapters and Monographs;
- An outline of how these monographs are elaborated and revised and of how to participate in this process;
- An outline of the policies and processes used to establish the European Pharmacopoeia Reference Standards; and
- An overview of the regulatory requirements of the Procedure for Certification of Suitability of the Monographs of the European Pharmacopoeia, and guidance and advice on preparing a successful dossier.
Download the Programme (Subject to change)
Who should attend?
This training course is of interest to national regulatory bodies, manufacturers, and to managers from quality control and regulatory affairs. It is ideal for new and junior staff members.