null Conference: The place of the Certification Procedure in the global regulatory environment

Certification of suitability 19/09/2017 PDF PRESENTATION

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​​​​

  Download the programme

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

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