Welcome to our new website! If this is the first time you are logging in on the new site, you will need to reset your password. Please contact us at firstname.lastname@example.org if you need assistance.
Your membership opens the door to free learning resources on demand. Check out the Member Knowledge Center for free webcasts, publications and online courses.
Hear from leaders around the globe as they share insights about their experiences and lessons learned throughout their certification journey.
RAPS recognizes that the current situation in Ukraine impacts our members and customers on many levels. If you are directly impacted by the current situation in the region and are challenged to meet your deadlines or obligations to RAPS, please reach out to email@example.com so that we can defer those challenges. Your health and safety are paramount to us.
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 an unprecedented number of 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 regulatory, clinical study conduct as well as quality assurance 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 this webcast, you will:
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.
Linyan Gao, PhD, Partner, China Med Device, LLC
Linyan Gao has 15 years of experience working with China’s regulatory affairs for chemical drugs and biologics. This includes 6 years of experience in the synthesis and quality control of APIs and drug products. Gao’s expertise includes reviewing documents of chemical drugs, biological products and imported drugs, as well as technical and formal review points. Proficient in communication with CDE-NMPA and successful drug application experience. PhD at Peking Union Medical College on microbiology and biochemical pharmacy.