Advanced Program in ICH-GCP

" The objective of this ICH GCP Guideline is to provide a unified standard for the European Union (EU), Japan and the United States to facilitate the mutual acceptance of clinical data by the regulatory authorities in these jurisdictions. "

Beginner 0(0 Ratings) 0 Students Enrolled
Created By Cliniversity Global Last Updated Sun, 17-Mar-2019 English
What will i learn?
  • Learner / aspirant will get in depth understanding of ICH-GCP which is the primary requirement of Clinical Research and Clinical Trials.

Curriculum for this course
0 Lessons 00:00:00 Hours
Requirements
  • B. Pharmacy, M. Pharmacy
  • Master's (Biotechnology, Biochemistry, Bioinformatics, Microbiology etc..)
  • Doctor's (BDS, BAMS, BHMS, BUMS, MBBS)
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Description
Good Clinical Practice (GCP) is an international ethical and scientific quality
standard for designing, conducting, recording and reporting trials that involve the
participation of human subjects. Compliance with this standard provides public
assurance that the rights, safety and well-being of trial subjects are protected,
consistent with the principles that have their origin in the Declaration of Helsinki,
and that the clinical trial data are credible.

The guideline was developed with consideration of the current good clinical practices of the European Union, Japan, and the United States, as well as those of Australia,Canada, the Nordic countries and the World Health Organization (WHO).

This guideline should be followed when generating clinical trial data that are
intended to be submitted to regulatory authorities.
The principles established in this guideline may also be applied to other clinical
investigations that may have an impact on the safety and well-being of human subjects.

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About The Instructor
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  • 2 Students
  • 9 Courses
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Clinical Research Program Trainer
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  • 00:00:00 Hours On Demand Videos
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  • Access On Mobile And Tv
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