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Hear from leaders around the globe as they share insights about their experiences and lessons learned throughout their certification journey.
This is an On-demand
recording from April 2020.
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
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.
Upon conclusion of the program,
about the products that have received
NMPA latest emergency approval due to COVID-19
Familiarize yourself with key pathways,
requirements and relevant
regulations for emergency
approval in both China NMPA
· Discover the urgently needed products
in AI, diagnostics, ICU care, imaging
· Understand the key implications to your market entry strategy
Who should attend?
in the life sciences industry
and business executives
Grace Fu Palma,
MBA, CEO, China Med Device, LLC
Dave McGurl, Director
of Regulatory Affairs, MCRA
Sheng, PhD, Project Manager, China Med Device, LLC
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
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.