Venue: NH Prague City, Mozartova 261/1, 15000 Prague, Czech Republic
Working language: English
The Procedure of Certification of Suitability to the Monographs of the European Pharmacopoeia (CEP) is an important tool for regulators and industry in preparing, assessing and managing marketing authorisations for medicinal products. The aim of this conference is to trace recent evolutions and changes of the Certification Procedure in a fast moving regulatory environment.
Expert speakers from industry and authorities from all over the world will present their experience. Particular importance will also be given to new developments and the place of the procedure in a globalised world.
Plenary sessions will include:
- Update on International initiatives
- The use of CEPs inside and outside Europe
- International cooperation for inspections of API manufacturers
Workshop sessions will cover the following topics:
- How to build a good CEP dossier – including the Top 10 Deficiencies and the control of elemental impurities
- GMP inspections of API manufacturers
- How to successfully prepare electronic submissions for CEP applications
Download the Programme (Subject to change)
Who should attend?
This conference should be attended by professionals from the pharmaceutical industry, regulatory agencies and academic institutions.