Venue: Novotel Bucharest City Centre, Bucharest, Romania
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 and the organisation of the work of the EDQM;
- 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.
The programme will be available soon.
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.
The fee for this event is:
This fee includes all documentation, lunches and refreshments.
It does not include accommodation and travel expenses.
By fax or email:
Please complete the registration form and send it to Public Relations by:
Before registering, read:
Terms of Supply for EDQM Events
The EDQM has block booked at reduced rates a number of rooms in the Novotel Bucharest City Centre, Romania.
Please send the reservation form by post, fax or e-mail directly to the hotel.