Genotoxic Impurities (GTI2012)

Venue: Radisson Blu Hotel

Location: Berlin, Germany

Event Date/Time: Jun 20, 2012 End Date/Time: Jun 21, 2012
Early Registration Date: Mar 30, 2012
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Description

What makes GTI2012 unbeatable?

Looking for the latest trends, progress, challenges and solutions from those teams at the forefront of genotoxic impurity identification and analysis? Read on for the key highlights from 2012’s event.

Gain exclusive insights from the ICH M7 Expert Working Group (EWG)…

… Lutz Mueller and Elisabeth Klenke deliver the latest from the EWG from the Industry and Regulatory stakeholder perspectives

Find out what the Regulator’s think about current GTI practices…

..and what their expectations are. Hear from and put your questions to the MHRA and Swissmedic

Hear in-depth expectations for how ICH M7 will affect you…

…Industry leaders discuss the implications for ICH M7 step 1 on Regulatory, CMC and toxicology teams

Discuss the latest in investigations into GTIs at the drug product level…

… 2012’s includes specific case studies assessing GTIs in the drug product in addition to considerations for drug product investigations throughout the agenda

Are you a past delegate? Discover something new at 2012’s event…

…with 13 completely new presentation topics and 9 new speakers

Unique benchmarking opportunities…

…with a new session dedicated to case studies from industry and their company approaches to GTI assessment – including investigations during early and clinical development as well as the SME perspective

Detailed considerations and strategies for investigating degradation products…

…with new insights from Sanofi Chemie’s Alain Guguet

Evaluating Extractables and Leachables for GTI risk…

…Discover more about what industry is concerned about from this relatively unknown risk as well as hear the latest form the Extractables and Leachables Safety Information Exchange group (ELSIE)

New trends and developments in the use of (Q)SAR/in-silico tools…

… A first hearing of white paper findings presented to the ICH M7 EWG regarding in-silico tool use across industry as well as case study insights from Sanofi-Aventis

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