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.
The plenary sessions focus on:
- Update on international initiatives
- The use of CEPs inside and outside Europe
- International cooperation for inspections of API manufacturers
Workshop sessions 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
Target audience
This conference is of interest to professionals from the pharmaceutical industry, regulatory agencies and academic institutions.
Download the presentations
Day 1: Plenary Session
- New developments of the European Pharmacopeia and their impact on the Certification Procedure, by Torbjörn Arvidsson
- The place of the Certification procedure in 2017 in the EU regulatory framework and beyond, by Hélène Bruguera
- Experience with CEPs from a European regulatory authority perspective, by Blanka Hirschlerová
- Experience with CEPs from the perspective of finished products manufacturers by Helen Robbins
- Experience with CEPs from the perspective of API manufacturers, by Marieke Van Dalen
- Experience with CEPs from the perspective of Indian manufacturers, by Gopal Joshi
- Experience with CEPs from the perspective of Chinese manufacturers, by Hong Xie
Workshop 1: How to build a good CEP application
Workshop 2: GMP inspections of API manufacturers
Workshop 3: How to successfully prepare electronic submissions for CEPs
Day 2: Plenary Session
- An overview of international initiatives in the regulatory sphere, by Cordula Landgraf
- The EU ASMF Work-sharing programme, by Nienke Rodenhuis
- The International Generic Drug Regulators’ Programme (IGDRP) initiative, by Gary Condran
- International cooperation for inspections of API manufacturers, by Monika Mayr
- CEPs: Views from Anvisa, Brazil, by Jeanne Sophie Cavalcante Lemos Gautier
- CEPs: Views from South Africa, by Mabatane Davis Mahlatji
- CEPs: Views from Canada, by Alison Ingham
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