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Hear from leaders around the globe as they share insights about their experiences and lessons learned throughout their certification journey.
As COVID-19 has become a pandemic, the time is critical for the support and reassurance that science can offer.
In response to the outbreak, Chinese regulatory authorities adopted emergency measures to fast-track the review and approval process.
China NMPA (former CFDA) issued over 70 Emergency Approvals of medical devices, diagnostic assays, protective supplies, and sterilization tools. The first batch of diagnostic tests were approved within five days. Furthermore, multiple drugs and biologics are in a clinical trial and various stages of approval. One such example, Remdesivir — an antiviral drug that selectively inhibits the RNA-dependent RNA polymerase of the influenza virus — is a potential agent against COVID-19 and was approved within three days to enter a clinical trial.
During this 90-minute webcast, our experts will explain related guidelines, emergency approval procedures, urgent importations, how they work in practice, what is required during the COVID-19 crisis, and what to expect moving forward. You will gain an understanding of how these changes will impact market entry to both the US and China.
The topics will cover both China's NMPA and US FDA regulatory updates. We will also discuss China's evolving market dynamics that may impact manufacturers of medical devices, IVD, drugs, and biologics.
Learning Level: Intermediate
Content is designed based upon the assumption that individuals have basic knowledge of the topic(s) and/or demonstrated competence related to the topic(s). Higher-level concepts are introduced during lectures; exercises requiring synthesis and/or application of concepts are incorporated into the activity.
Who should attend?
Grace Fu Palma, MBA, CEO, China Med Device, LLC
Dave McGurl, Director of Regulatory Affairs, MCRA
Yan Sheng, PhD, Project Manager, China Med Device, LLC
Yan Sheng, PhD, is the project manager of China Med Device. She grew up in China working in the life science industry in both the US and China. Sheng received her PhD at Oregon State University. Her PhD studies focused on natural products discovery from the microbial world. With more than 6 years’ experience in the academic field, she is familiar with cutting edge technologies in both chemistry and microbiology.
Lijun Xiao, Partner of China Med Device, LLC
Lijun Xiao has over 20 years of China NMPA drug and biologics regulatory and clinical affairs experience. As the vice president of regulatory affairs at Medicon and a senior director for Fountain Medical Development, Xiao is a strategic advisor of early clinical development for many innovative drugs. She has had successful submissions of over 100 innovative drugs and biologics, IND and NDA for chemical drugs, biological products and imported drugs from Amgen, Bayer, Novartis and AstraZeneca.