Advanced program in ICH-GCP

The objective of the 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.



What will I learn?
  • Candidate 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
Requirements
  • B. Pharmacy and M. Pharmacy
  • Masters (Biotechnology, Biochemistry, Bioinformatics, Microbiology etc..)
  • Doctors (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
clinical research clincal trails
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  • 45 Students
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₹8000
Includes:
  • 0 Lessons
  • Four Month Access
  • Self Paced Learning
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