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Agenda at a Glance
Agenda at a Glance
| Conference Day 1 - Thursday December 3, 2009 |
8:00
Conference Registration & Morning Coffee 8:45
Chairperson’s Opening Remarks and Seminar Overview Chris Riley, President, RILEY AND RABEL CONSULTING SERVICES
9:00
Regulatory Overview – New FDA’s Guidance for Industry Genotoxic and Carcinogenic Impurities in Drug Substances and Products Chris Riley, President, RILEY AND RABEL CONSULTING SERVICES
9:15
Moving Beyond the Regulations – You Know What They’ve Told You – Here is What you Need to Figure Out for YourselfFenghe Qiu, Principal Scientist and Leader of the Trace Analysis Group, BOEHRINGER-INGELHEIM
10:00
Morning Networking Break 10:30
Establishing Industry Wide Standards for the Control of Genotoxic Impurities Richard Thompson, Chemical and Analytical Development, Novartis
11:00
Regulatory & Risk Assessment Best Practices Chris Riley, President, RILEY AND RABEL CONSULTING SERVICES
Fenghe Qiu, Principal Scientist and leader of the Trace Analysis Group, BOEHRINGER-INGELHEIM
David DeAntonis, Senior Director, PFIZER
Fenghe Qiu, Principal Scientist and leader of the Trace Analysis Group, BOEHRINGER-INGELHEIM
David DeAntonis, Senior Director, PFIZER
12:00
Networking Roundtable Luncheon for Faculty and Participants
1:30
Case Studies of GTIs Assessment and Analytical Control in API Development
Yong Chen, PhD, Research Investigator, Analytical Chemistry, Process R&D, ABBOTT
Panel Discussion
2:15
A Systematic Analytical Strategy for Determination of Trace level Genotoxic Impurities in Pharmaceuticals: An Industrial Perspective David Liu, Mass Spectrometry Team, Analytical Sciences, Chemical Development, GlaxoSmithKline
3:15
Afternoon Networking break Process & Analytical Chemistry
3:30
Techniques and Tools to Analyze for Low Level of Impurities Zhanna Yuabova, PhD, Analytical Sciences, BOEHRINGER INGELHEIM PHARMACEUTICALS
Vladimir V. Papov, Jr., PhD, Principal Scientist, Analytical Science, BOEHRINGER INGELHEIM PHARMACEUTICALS, INC
Vladimir V. Papov, Jr., PhD, Principal Scientist, Analytical Science, BOEHRINGER INGELHEIM PHARMACEUTICALS, INC
4:00
Global Team Process Approach Including Process Chemistry, Analytical and QC/QA Edgar Nicolas, Senior Director, Global Analytical Sciences Global Coordinator, GTIs, SANOFI-AVENTIS
Zhanna Yuabova, PhD, Analytical Sciences, BOEHRINGER INGELHEIM PHARMACEUTICALS
Zhanna Yuabova, PhD, Analytical Sciences, BOEHRINGER INGELHEIM PHARMACEUTICALS
4:30
Analytical Methods and Techniques to Understand and Contain Low Levels of Impurities Zhanna Yuabova, PhD, Analytical Sciences, BOEHRINGER INGELHEIM PHARMACEUTICALS
Edgar Nicolas, Senior Director, Global Analytical Sciences Global Coordinator, GTIs, SANOFI-AVENTIS
Edgar Nicolas, Senior Director, Global Analytical Sciences Global Coordinator, GTIs, SANOFI-AVENTIS
5:15
Day One Concludes| Conference Day 2 - Friday December 4, 2009 |
8:30
Morning Coffee 9:00
Chairperson’s Recap of Day One Chris Riley, President, RILEY AND RABEL CONSULTING SERVICES
Relationship of Forced Degradation Studies and GTIs- Structural Determination and Assessment of GTIs Steven W Baertschi, PhD, Senior Research Advisor, ELI LILLY & COMPANY
9:45
Hot Topics Interactive Round Tables Chris Riley, President, RILEY AND RABEL CONSULTING SERVICES
10:00
GROUP A: Process Chemistry
Mark Kleinman, Chemical Development Analytical Sciences, GlaxoSmithKline
GROUP B: Stress Testing and Degradation
Steven W Baertschi, PhD, Senior Research Advisor, ELI LILLY & COMPANY
GROUP C: Regulatory
Chris Riley, President, RILEY AND RABEL CONSULTING
GROUP D: Analytical
Brad Mueller, Associate Director, Analytical Development, ASTRAZENECA INVITED
10:45
Morning Networking Break11:00
Facilitator’s Recap of Group Discussions 12:00
Seminar Concludes