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Tuesday, June 25 • 4:15pm - 4:45pm
#299.1 CH: Challenge of Regulatory Starting Material Designation and Its Implication on the Global Markets for the Post Approval Process

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Component Type: Workshop
Level: Intermediate

Definition of the Regulatory Starting Material and its Impact on the Drug Substance manufacturing

Learning Objectives

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.

Chair

Xuhong Cheng, DrSc, PhD

Speakers
avatar for Xuhong Cheng

Xuhong Cheng

Associate Director, GRS - RA, Janssen, Pharmaceutical Companies of Johnson and Johnson
Xuhong holds a PhD degree in Organic Chemistry. She has eighteen years of pharmaceutical industrial experience including fourteen years of regulatory CMC for small molecule and biologic-pen injector combination products.

Tuesday June 25, 2019 4:15pm - 4:45pm PDT
Content Hub Sails Pav San Diego Convention Center 111 W Harbor Drive, San Diego, CA 92101 USA
  16: Content Hubs, Workshop |   10: RegCMC-Product Quality, Workshop