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REGULATORY : Comprehensive Guide for Generic Drug Trials The Unique Concerns of Recombinant DNA Research TRIAL DESIGN : A Crash Course in Adaptive Also in this issue : Sponsors Challenged by Globalization, GCP Inspections Unite EMEA and FDA, Post Credit Crunch R&D Opportunities

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eCTD Training Efforts

A panel of early eCTD adopters address training efforts on the evolving format.