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Based on the source: http://www.fda.gov/downloads/Drugs/…/Guidances/UCM269919.pdf
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About the Author: Artem Andrianov, Ph.D., MBA
Professional in the integration of data-driven Risk-based Quality Management (RBQM) process in international clinical trials of pharmacology.
Speaker at regional and global conferences such as: DIA, Health 2.0, DGGF, etc.
18+ years of experience in data quality projects and biostatistics for the pharmaceutical industry.
Life passion: improving clinical research with RbM, driving the RBQM research to new frontiers for CROs, pharma and biotech companies.
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