Component Type: Tutorial
CE: ACPE 3.25 Knowledge UAN: 0286-0000-20-504-L04-P; CME 3.25; IACET 3.25; RN 3.25
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Since NMPA becomes ICH regulatory member, Chinese regulatory landscape seems much more harmonious with global standards and practices. Currently, Chinese GCP guidelines published by NMPA have been significantly adopted ICH requirements, which makes it possible directly to utilize global trial data to submit NDA NMPA. NMPA is also enhancing inspective forces on the quality and integrity of clinical trial outcomes, including data from oversea trials. The procedures of IND/NDA review and approval have been greatly reformed, such as 60 days IND silent system and filing site qualification on file instead certificate process etc. Quality of trial data is becoming more essential as evidence of supporting NDA approval. All of these updates are sure to impact the IND/NDA strategies in China. This short course will provide insights into critical considerations impacting IND/NDA practices involving in drugs development in China and upcoming NMPA reformations of regulatory submission review and approval.
Back to DIA 2020 Short CoursesWho should attend? Regulatory affair professionals, Drug development professionals, Clinical trial management, Monitors, Data management professionals, Clinical operation professionals.
Learning Objectives Describe basic NMPA regulatory requirements for IND/NDA submission; Discuss how to support simutanous regulatory submissions to FDA/NMPA authorities; Compare the similarity and difference between Chinese GCP and Western GCP; Discuss an overview of the updated Chinese GCP guideline of IND drug trials; Describe utilization of oversea clinical CSR for NMPA submission; Identify updated NMPA requirements of data quality/integrity.
