Challenges Facing CMC Organizations in the Changing Business and Regulatory Environment

Chair(s):
Bordawekar, S. V., Abbott Laboratories
Co-chair(s):
Clark, P., DynoChem

In recent years, the Pharmaceutical industry has been facing significant challenges due to patent expirations for blockbuster drugs, rising R&D costs, increased regulatory expectations and fewer new product approvals. These pressures have resulted in major changes to the development strategies of CMC organizations across the industry. New strategies call for enhanced scientific understanding (QbD) to drive development efficiency and globalization of R&D to manage costs. This session will invite speakers from industry to discuss these challenges and various approaches to address them.

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2010 Annual Meeting
AIChE Members $150.00
AIChE Graduate Student Members Free
AIChE Undergraduate Student Members Free
Non-Members $225.00
Comprehensive Quality by Design in Pharmaceutical Development and Manufacture only
AIChE Members $100.00
AIChE Food, Pharmaceutical & Bioengineering Division Members Free
AIChE Graduate Student Members Free
AIChE Undergraduate Student Members Free
Non-Members $150.00