Global Certificate in Regulatory Affairs Documentation Writing
-- ViewingNowThe Global Certificate in Regulatory Affairs Documentation Writing course is a comprehensive program designed to meet the growing industry demand for expertise in regulatory affairs documentation. This course emphasizes the importance of accurate and compliant documentation in the medical device, pharmaceutical, and biotechnology industries.
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โข Regulatory Affairs Fundamentals
โข Global Regulatory Documentation Requirements
โข Good Documentation Practices in Regulatory Affairs
โข Writing Regulatory Submissions (eCTD, NeeS)
โข Regulatory Writing for Clinical Trials (Protocols, IBs, CSRs)
โข Labeling and Package Inserts for Global Markets
โข Regulatory Writing for Pharmacovigilance (PSURs, DSURs)
โข Regulatory Intelligence and Literature Searching
โข Quality Management in Regulatory Documentation Writing
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