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Recorded Webinar
FDA Guidance for ICH GCP E6 R2 Means for Sponsors and CROs
timelapse 60 mins with 10-15 mins of Q and A
Note:
This webinar occured in the past
Along with recorded webinar, copy of presentation slides will be shared
Recorded Webinar can be played unlimited times
Speaker/Presenter
Short Abstract
FDA Guidance for Good Clinical Practice (GCP) is an international quality standard defined by the International Council for Harmonization (ICH) that governs ethical and scientific considerations for designing, conducting, recording and reporting trials involving human subjects. Compliance with FDA Guidance for GCP in clinical trials helps to assure that the rights, well-being and safety of trial participants are protected and that the data generated in the trial is credible.
Learning Highlights:
- Introduction " The Principles of ICH GCP"
- Identify three changes that impact sponsors/CROs and individual roles
- Explain the impact of the revisions on clinical trial conduct and organizational practices
- Discuss opportunities for implementing the revised guideline
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