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Challenge of Regulatory Starting Material Designation and Its Implication on the Global Markets for the Post Approval Process
Session Chair(s)
Xuhong Cheng, DrSc, PhD
Associate Director, GRS - RA
Janssen, Pharmaceutical Companies of Johnson and Johnson, United States
Definition of the Regulatory Starting Material and its Impact on the Drug Substance manufacturing
Learning Objective : Interpret the key elements for the designation of the regulatory starting material under ICH Q11 and describe its regulatory impact on the post approval changes in the global markets.
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