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Lifecycle Registration Change Management
Session Chair(s)
May LI
Executive Director, Regulatory Affairs
BeiGene, China
Drug change management runs through the whole process of drug life cycle. Good change management improves the efficiency and success of drug development, ensures patients’ safety in medication, and also ensures the continuous development of products in the market. In light of the new Drug Registration Regulation together with the related supplementary regulations and guidance documents, this chapter summarizes the change management during the process of drug R&D, the change management of drug prescribing information and other post marketing change management requirements. The speakers will compare the previous and new regulations, identify remain issues uncleared in the new regulation and provided related suggestions for industry colleagues after the new regulation implementation