CTD, CEP and Active Substance Master File 23-24 March 2010 Munich, Germany Please click here to view the program of this conference or course To book for this program, just click on the option: Book this option: Non-ECA Members (EUR 1790,--) Book this option: ECA Members (EUR 1611,--) Book this option: EU GMP Inspectorates (EUR 895,--) Book this option: APIC Members (does not include ECA membership) (EUR 1700,--)
At this conference we offer a Conference Exhibition. Please click here in order to view the registration form (PDF) for exhibitors.
Objectives This education course is intended to provide guidance on the format, content and submission procedures for the pharmaceutical documentation of the quality of the drug substance for different types of dossiers, the CTD, the CEP and the European ASMF and the US-DMF. Furthermore, the impact of the new variations regulations will be discussed. Participants will have the opportunity to choose 2 out of 4 parallel workshops: Stability studies and establishing a retest date Description of the manufacturing process How to compile data for impurities and residual solvents Questions and answers of the CEP procedure Background In Europe there are four ways to document the quality of the drug substance for the purpose of marketing authorisation since 1992: Certificate of Suitability of the pharmacopoeial monograph (CEP) Full details of manufacture (according to CTD Module 3 Quality of Drug Substance) European Active Substance Master File (ASMF; former Drug Master File, DMF) Other evidence of suitability of the pharmacopoeial monograph In the US, the quality of the drug substance can be documented as part of the CMC Dossier or in a US-DMF.