Showing results for "ich"

The Big Reveal - ICH E8 Renovation
It’s Finally Here On October 6, 2021, the International Council on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for ...
Navigating the Transition from ICH E6(R2) to ICH E6(R3): Key Changes and Best Practices for Clinical Trial Sites
The International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) E6 guideline for Good Clinical Practice ...
ICH – Comparison Between ICH GCP E6 and U.S. FDA Regulations
Expands on the discussion presented in ICH Overview comparing ICH GCP E6 guidelines and U.S. FDA regulations 21 CFR Parts 50 and 56. Presents the majo...
ICH - Comparison Between ICH GCP E6 and U.S. FDA Regulations
Explains the legal status of the ICH guidelines in the U.S., how investigators determine whether to adhere to the ICH guidelines, and important differ...
GCP for Clinical Trials with Investigational Drugs and Biologics (ICH Focus)
The GCP ICH Basic course covers the International Council for Harmonisation (ICH) E6(R3) Good Clinical Practice (GCP) guideline’s essential topics f...
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