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Efficient Preparation of Global CMC Dossiers
Session Chair(s)
John Smart, PHD
Executive Director, CMC Regulatory Affairs
Astrazeneca, United Kingdom
Preparation and maintenance of dossiers for a global market is exceedingly complex, due to different expectations for regulatory agencies across the globe. Efficiently creating a dossier to effectively meet worldwide requirements requires careful planning. This session will provide some practical and pragmatic approaches for managing the complexity of global CMC dossiers.
Learning Objective : Describe the key regulatory considerations for preparation of a global CMC dossier; Discuss some of the global harmonization efforts that are underway.
Speaker(s)
Global CMC Dossiers: Preparation is Key
Angela McGillivary, PHD
PAREXEL, United Kingdom
Principal Consultant
Regulatory CMC Roadmaps for Fast-Evolving Global Markets (Brazil, China, India, Russia and Turkey)
Monika Jain, PHD
PPD, United States
Manager , Regulatory Affairs CMC, Regulatory Development Solutions