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Genotoxic Impurities in Manufacturing
October 11, 2022
Digital Conference8:30AM EST // 1:30PM BST // 2:30PM CEST
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Genotoxic Impurities in Manufacturing - ET (Eastern Time, GMT-05:00)

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Showing 1 of 1 Streams
8:30am - 8:45am
Welcoming Remarks
  • Lottie Leinfellner - Digital Events Conference Producer, Informa Connect, UK
8:45am - 9:15am
A Pathway to Nitrosamine Free (?) Pharmaceuticals - Does the Road Wind Uphill all the Way?
  • Aloka Srinivasan - Principal and Managing Partner, Raaha LLC, USA
9:15am - 9:45am
Quantitative Analysis of In Vivo Mutagenicity Dose Response Data for Risk Assessment and Regulatory Decision-making: A Case Study of Nitrosamines
  • George Johnson - Associate Professor, Past-President EEMGS, Swansea University Medical School, UK
9:45am - 10:05am
Coffee Break & Networking
10:05am - 10:35am
Leachable Impurities, how risk management fits with current and future ICH guidance
  • Jason Creasey - Managing Director, Maven E&L Ltd., UK
10:35am - 11:05am
A Strategy to Carry Out Risk Assessment of Mutagenic Impurities in the Industry, in Order to Avoid the Requirement of Regulatory Agencies
  • Ana de Avelar Muraca - DMF Analyst, Apsen Farmacêutica, Brazil
11:05am - 11:50am
Panel Discussion: Dealing with Impurities from Early to Late-Stage Development; How to Tackle this in a Safe and Time/Cost-Effective Manner
  • Olivier Dirat - Senior Director, Pfizer, UK
  • Jim Harvey - Non-Clinical Safety (Target and Systems Safety), GlaxoSmithKline, UK
  • Rodney Parsons - Executive Director Chemical Development, Bristol-Meyers Squibb, USA
11:50am - 12:10pm
Coffee Break & Networking
12:10pm - 12:40pm
Avoiding N-nitrosodimethylamine formation in metformin pharmaceuticals by limiting dimethylamine and nitrite
  • Joerg Schlingemann - Principal Expert Quality Control Systems, Merck Healthcare KGaA, Germany
12:40pm - 1:10pm
Computational and Predictive Methods for Assisting with Risk Assessment during Drug Synthesis
  • Michael Burns - Principal Scientist, Lhasa Limited, UK
1:10pm - 1:40pm
Analytical Methodology for Improved Sensitivity and Quantification of Genotoxic Impurities
  • C. J. Venkatramani - Senior Principle Scientist, Genentech, USA
1:40pm - 2:40pm
End of Day/ Networking on the Platform
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