China currently has 1,380 healthcare institutions authorized to conduct clinical trials, in accordance with the "Quality Management Practice Specification for Clinical Trials of Medical Devices" (known read more
Welcome Karen F. Underwood, MS Quality Improvement and Compliance Specialist Center for Vascular Research Division of Vascular Surgery The University of Maryland Medical Center and Baltimore VA read more
This message was posted by a user wishing to remain anonymous Hello Dan, You nailed it. Very well explained and informative reply. Appreciated - have a great weekend.
Thanks for sharing ------------------------------ [Robert] [Falcone] PhD, FTOPRA, FRAPS ------------------------------
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China currently has 1,380 healthcare institutions authorized to conduct clinical trials, in accordance with the "Quality Management Practice Specification for Clinical Trials of Medical Devices" (known as China GCP) implemented since March 2022. These ...
In this instance a sponsor wishes to proceed to Phase 1 under an active IND where the drug is an antibody (1) drug conjugate. Because Ab1 is not an option for commercialization, the sponsor wishes to obtain an approved comparability protocol to substitute ...
Join us for our next open house on May 17th! https://www.linkedin.com/events/regulatoryaffairstoastmasters-r7181644189183418369/ ------------------------------ Elizabeth Bereza RAC, MSRA Senior Regulatory Affairs Specialist Indeio LLC Raleigh ...
This message was posted by a user wishing to remain anonymous Hi, Does anyone know if there is a resource that can be used to know if any sanctions were placed to do business of medical device or drugs by United States in certain countries. ...
This message was posted by a user wishing to remain anonymous Hello, I am curious if anyone has any experience with Medical Device Software and pushed or automatic updates and patches. It seems that with the release of the Cybersecurity in Medical ...
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