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Home > Drug News > FDA's Ajaz Hussain and Purdue's Ken Morris Lead a Forum on ICH Q8
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FDA's Ajaz Hussain and Purdue's Ken Morris Lead a Forum on ICH Q8
(PRWEB) August 15, 2005 -- On Friday, September 9, at the Hyatt Regency in Princeton, N.J., Dr. Ken Morris, Professor and Associate Head of Industrial and Physical Pharmacy at Purdue University, and Dr. Ajaz Hussain, Deputy Director of the Office of Pharmaceutical Sciences, CDER, FDA, will discuss ICH Q8 and how to get pharmaceutical process development "right the first time."
Streamlining drug development is a key to reducing drug costs and improving quality, and data management is a critical, yet often overlooked, part of the process. A new series of breakfast seminars hosted by the software firm, Conformia, Inc., and sponsored by Pharmaceutical Manufacturing magazine, will focus on optimizing information management to streamline the drug development process.
The September 9th forum will be the first in this series of quarterly "scaleup optimization" seminars. Drs. Hussain and Morris will lead an interactive discussion and also review the key goals and principles of ICH Q8. A case study will be presented showing how a leading drug company leveraged its information management to optimize its drug development efforts.
Designed for chemists, engineers and other professionals involved in drug development, this brief and interactive session will run from 8 AM until 11:30 AM on Friday, September 9, 2005. Through discussion and illustrations, it will show how the principles and objectives of ICH Q8 can be incorporated into drug development efforts.
Attendees will be able to discuss what organizations should consider when they design chemical and/or biological process routes, and also address supporting scaleup business and information management issues.
Talks will be followed by a real-life case study showing how a Top 10 pharmaceutical firm gained better control of its information management for drug development, and how it leveraged development data into an effective knowledge management framework. The seminar will close with a panel discussion entitled "From Concept to Practice: Prescription for Implementing ICH Q8 and Process Understanding," which will involve representatives from leading pharmaceutical and biopharmaceutical development organizations.
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