Global Certificate Biopharma Regulatory Compliance
-- ViewingNowThe Global Certificate in Biopharma Regulatory Compliance course is a comprehensive program designed to meet the growing industry demand for professionals with a deep understanding of regulatory compliance in the biopharmaceutical sector. This course is vital for career advancement in biopharma, as it provides learners with essential skills in regulatory strategies, quality assurance, clinical trials, and pharmacovigilance.
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โข Global Regulatory Landscape: An overview of global biopharma regulatory bodies and their roles, including FDA, EMA, PMDA, and others.
โข Regulatory Compliance Foundations: An introduction to the principles of regulatory compliance, including Good Manufacturing Practices (GMP), Good Laboratory Practices (GLP), and Good Clinical Practices (GCP).
โข Regulatory Strategy and Planning: A guide to developing and implementing a regulatory strategy, including the creation of a regulatory affairs roadmap and timelines.
โข Clinical Trial Regulation: A deep dive into the regulations surrounding clinical trials, including ICH-GCP guidelines, IND/CTA submissions, and safety reporting.
โข Quality Management Systems: An exploration of Quality Management Systems (QMS) and their importance in regulatory compliance, including ISO 13485 and ISO 9001.
โข Pharmacovigilance and Pharmacoepidemiology: An overview of pharmacovigilance and pharmacoepidemiology, including adverse event reporting, signal detection, and risk management.
โข Regulatory Submissions and Documentation: A guide to preparing and submitting regulatory documents, including eCTD submissions, labeling, and packaging.
โข Regulatory Inspections and Audits: An overview of the regulatory inspection and audit process, including preparation, execution, and follow-up.
โข Regulatory Intelligence and Horizon Scanning: A guide to monitoring and staying up-to-date with regulatory changes, including horizon scanning, trend analysis, and regulatory intelligence gathering.
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