Please join the AAPS Bioanalytical Community on Oct 27th@ noon EDT for an Open Scientific Discussion:
Regulated Bioanalysis of Samples from Clinical Trial Participants in China: Navigating Challenges and Opportunities
In the last 10-15 years, clinical trials conducted in China and global clinical trials including participants in China have increased. Consequently, regulated bioanalysis of samples collected from these participants has either required analysis in laboratories in China or export of those samples to testing sites in other geographies. Over the last 10+ years, both of these approaches have presented unique challenges. New guidances issued over the previous 2-3 years by the Human Genetic Resources Administration of China (HGRAC) and the National Medical Products Administration of China (NMPA) have helped to clarify the exportation and management of analysis of biological samples from clinical trials. With the increasing importance of China in the development of pharmaceutical products, the AAPS is hosting an Open Scientific Discussion focused on the regulated bioanalysis of samples from clinical trial participants in China. The approaches to manage bioanalysis in China and/or export of clinical samples will be reviewed, including the role of China Inspection and Quarantine (CIQ, i.e., Customs) and the HGRAC.
Panel Members -
Eric Woolf (Consultant, Beyond M10 Bioanalytical Consulting)
Michael Partridge (Sr. Dir Bioanalytical Sciences, Regeneron)
Lisa Borbridge (Dir Bioanalytical Outsourcing Management, Abbvie)
William Annes (Sr. Dir Clinical Lab Sciences- Immunology, Eli Lilly)
Molly Karlinsky (Senior Director External Sourcing & Pipeline Management
J&J Innovative Medicine)
Abigail Trenchak (Senior Bioanalytical Manager, Genentech)
Moderator: Sanjeev Bhardwaj (Moderna)
For more information, including calendar invites and virtual meeting login info, please visit the EVENT PAGE .
Have an idea for an upcoming session?
Please contact the OSD Committee Co-Chairs, @Sanjeev Bhardwaj & @Laurelle Calliste
We start at noon EST sharp. Please dial in before noon to avoid interruptions and mute yourself until the Q&A starts.
You are encouraged to submit questions in the discussions section of the Bioanalytical Community Page before the event.
(Please remain muted and submit your questions via the Chat feature of the MS Teams Meeting)
Please join from your computer, Tablet, or smartphone.
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Microsoft Teams Meeting
Join the meeting now
Meeting ID: 226 568 011 546 4
Passcode: 335mQ2fc
#bioanalysis #Bioanalytical #OSD #OpenScientificDiscussions
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Sanjeev Bhardwaj
Moderna Therapeutics
Cambridge, MA.
[email protected]Disclaimer: Opinions expressed are solely my own and do not express the views or opinions of my employer.
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