IMPURITIES,
IMPURITIES,
IMPURITIES ~ To be
Held in Nice, France

Conference Date: 24 Jun 2009-13 Jul 2009
Conference Ref: A6-6109
Fee: £1650
Venue: Radisson Blu Hotel, Nice, France

NO VAT will apply for this meeting.

This conference takes a look at impurities from numerous perspectives with presentations on avoidance, detection, control, reduction/removal and safety of impurities in new and existing drug substances and medicinal products, embracing synthetic chemicals and biological materials. Newly prepared substances and products, scaled-up processes and stored goods all present different challenges regarding purity and its maintenance.

Chemical and pharmaceutical development issues, analytical challenges and some recent analytical achievements will be reviewed and addressed, international and other official guidelines that help the industry and regulators to harmonise will be explained and regulatory expectations and requirements will be described by an eminent panel of speakers from industry, academia and the authorities. Attention will be paid to updating delegates about relevant impacts of recent changes in the pharmaceutical legislation and in the European Pharmacopoeia concerning the control of impurities. There will also be a special critical focus on Genotoxic Impurities and the appropriate EU guidelines, explanations of ALARP(as low as reasonably practical) and TTC (threshold of toxicological concern) concepts, on structural alerts and on regulatory problems in the interpretation, understanding and sensible application of the guidelines.