Forced Degradation Studies
Agenda Day Two
Wednesday, January 24th, 2007
| 8:15 | Morning Coffee | ||||
| 8:45 |
Co-Chair's Opening Remarks and Recap of Day One Karen Alsante, PhD, Associate Research Fellow, Analytical R&D, Solid State Characterization, PFIZER GLOBAL RESEARCH AND DEVELOPMENT Steven W. Baertschi, PhD, Research Fellow, Analytical Sciences R&D, Chemical and Structural Characterization Team, ELI LILLY AND COMPANY Allen C. Templeton PhD, Associate Director, Pharmaceutical Analytical Chemistry, MERCK & COMPANY |
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| 9:00 |
Forced Degradation Studies of Drug Products – Impact on Long Term Performance of the Methods Dilip R. Choudhury, PhD, Associate Director, Analytical Development/Development Quality Control, SCIOS INC., A JOHNSON & JOHNSON COMPANY |
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| 9:30 |
Evaluating Suspensions for Conducting Stress Testing Studies of Drugs with Low Aqueous Solubility Biren Joshi, PhD, Investigator, Structural Chemistry/Analytical Sciences, CDD, GLAXOSMITHKLINE |
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| 10:00 |
Increase the Probability of Successfully Developing a Stable Dosage Form in a Timely Fashion through Appropriate Design of Drug-Excipient Interaction Studies Donald C. Monkhouse, PhD, President, APRECIA PHARMACEUTICALS COMPANY |
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| 10:30 | 30 Minute Networking and Refreshment Break | ||||
| 11:00 |
Breakout Session Close the Information Gap and Open Communication to Strengthen your Forced Degradation Studies Knowledge Base |
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| 12:00 | Luncheon | ||||
| 1:15 | Attend your choice of any Roundtable session | ||||
| 1:45 |
Attend your choice of a 2nd Roundtable session
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| 2:30 |
REGULATORY Dan Reynolds, Team Manager, GLAXOSMITHKLINE |
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| 3:00 |
Part A: Early Development Degradation Studies and IND IMPD Strategy Pfizer Presents Two Part Case Study on Best Practice Regulatory Filing Methods for Early and Late Stage Development Karen Alsante, PhD, Associate Research Fellow, Analytical R&D, Solid State Characterization, PFIZER GLOBAL RESEARCH AND DEVELOPMENT |
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| 3:30 |
Part B: Late Stage Degradation Studies and NDA/Japan Filing Strategy Alex Opio, Scientist, Analytical R&D, PFIZER GLOBAL RESEARCH AND DEVELOPMENT |
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| 4:00 |
Regulatory Filing Methods David T. Lin, Sr. Consultant/Former FDA Regulator, BIOLOGICS CONSULTING GROUP Alex Opio, Scientist, Analytical R&D, PFIZER GLOBAL RESEARCH AND DEVELOPMENT Dan W. Reynolds, PhD, Team Manager, GLAXOSMITHKLINE Satyam Upadrashta, Sr. Director of Regulatory Affairs, ARADIGM |
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| 4:30 |
Conference Concludes |
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