Contenuti:
Nel corso della giornata sono stati trattati i seguenti argomenti:
Overview on Council of Europe, EDQM
· Pharmaeurope and how is a monograph born
· How to use and navigate the European Pharmacopoeia
· About USP: history, policy and rules
· Pharmacopoeial Forum: a correct use of the tool
· Correct use of JP pharmacopoeia as reference standard in Japanese application
· Harmonization of JP with other standards
· Certificate of Suitability: history and a correct use
· How and when to apply for a CEP
· CEP: the industry perspective, perceived advantages and difficulties encountered
· Common deficiencies during the assessment of CEP dossiers
· Beyond the CEP: the control strategy to assure quality of manufacturing
Visualizza relazioni