Date and Time:
TUE 26 JAN 2021, 9:00 AM - 10:30 PM Eastern US Standard Time
Description:
Join us to review the history of China e-submission regulatory requirements since the late 2000s when the first data submission related guidance was published. The webinar will also focus on the latest provisional e-submission guideline released in July 2020, including the detailed requirements on the foreign database used to support new drug application in China. Finally, the key China NMPA e-submission requirements will be compared with US FDA’s and Japan PMDA’s, followed by a 30-minute Q&A session.
Presenters:
- Zibao Zhang, VP Business Development, dMed Pharmaceutical Co., Ltd.
- John Wang, Director, Programming, dMed Pharmaceutical Co., Ltd.
- Victor Wu, EVP, Data Science, Beijing Data Science Express Consulting Co., Ltd.
- Stanley Wei, Group Head of Data Management and Innovation, Novartis
Webinar Language: English
Click here to ensure your machine has the necessary requirements to run CDISC webinars (run by LogMeIn).