Global Certificate in Drug Approval Documentation
-- ViewingNowThe Global Certificate in Drug Approval Documentation course is a comprehensive program designed to meet the growing industry demand for professionals with expertise in drug approval documentation. This course emphasizes the importance of regulatory compliance and provides learners with the essential skills required to navigate the complex world of drug approval processes.
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⢠Drug Development Process
⢠Preclinical Research and Documentation
⢠Clinical Trials Phases and Documentation
⢠Regulatory Affairs and Compliance
⢠Safety and Pharmacovigilance Documentation
⢠Global Harmonization and Regional Regulations
⢠Quality Management Systems and Documentation
⢠CMC (Chemistry, Manufacturing, and Controls) Documentation
⢠Global Drug Approval Pathways and Strategies
⢠eCTD (Electronic Common Technical Document) Structure and Preparation
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