Showing results for "ich"

FDA Announces New Draft Guidance: ICH E6(R3)
Introduction The U.S. Food and Drug Administration (FDA) has taken a significant stride towards modernizing clinical trials by releasing a draft guid...
GCP Refresher - International Conference on Harmonisation (ICH): GCP Requirements
Provides a basic understanding of the ICH’s role and impact on conducting clinical research according to GCP. It describes the purpose of ICH and id...
GCP Refresher - International Conference on Harmonisation (ICH): GCP Requirements
Provides a basic understanding of the ICH’s role and impact on conducting clinical research according to GCP. It describes the purpose of ICH and id...
In-Depth Review of ICH E6 and TransCelerate Minimum Requirements
Fulfills mutual recognition training requirements for the course by reviewing the remaining topics from the ICH E6 guideline not previously covered in...
FDA Publishes ICH E8(R1) Guidance
The FDA has published the guidance document, “E8(R1) General Considerations for Clinical Studies," to assist those that design clinical studies by o...
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