Impurities - Special focus on genotoxic impurities and heavy metals 23-25 May 2012 Copenhagen, Denmark 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 1990,--) Book this option: ECA Members (EUR 1790,--) Book this option: EU GMP Inspectorates (EUR 995,--) Book this option: APIC Members (does not include ECA membership) (EUR 1890,--)
At this conference we offer a Conference Exhibition. Please click here in order to view the registration form (PDF) for exhibitors.
Objectives This conference will provide an opportunity to reinforce and expand your knowledge of the general area of impurities in chemical entities from initial development to the market with emphasis on Detection, profiling and control of impurities in drug substances, intermediates and drug products Detection, control and reporting of genotoxic impurities How to control genotoxic impurities in herbal medicinal products How to deal with residues of metal catalysts and reagents Extractables and leachables as a source of impurities Residual solvents as impurities in marketed products Impurities in biotechnology products Analytical methods used for detection of impurities How to report impurities in regulatory submissions This event is designed to provide a comprehensive review of impurities analysis and characterisation in drug substances and drug products and their recording and reporting. Background Setting specifications for impurities are one of the most critical topics for a registration application. Impurities analysis in drug substances and drug products and their recording and reporting is quite often a challenge for the scientific experts in development and routine production. This challenge is even bigger when potential genotoxic impurities or residual metal catalysts have to be qualified and quantified. There is a specific EMA guideline on the specification limits for residues of metal catalysts or metal reagents which came into effect on 1 September 2008. The conference addresses all personal involved in development of drug substances and drug products from scientific staff to laboratory heads. The conference also covers the needs of experts in regulatory submissions or assurance and those involved in chemical and pharmaceutical manufacture.