Executive Development Programme in Biotech Regulatory Affairs
-- ViewingNowThe Executive Development Programme in Biotech Regulatory Affairs is a certificate course designed to provide learners with critical skills in navigating the complex regulatory landscape of the biotech industry. This program emphasizes the importance of regulatory compliance and its impact on business success, fostering a deep understanding of regulations, guidelines, and procedures at local, regional, and international levels.
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โข Introduction to Biotech Regulatory Affairs
โข Global Regulatory Landscape for Biotech Products
โข Regulatory Pathways for Biotech Drug Development
โข Biotech Product Preclinical and Clinical Trials Regulation
โข Quality Systems and Current Good Manufacturing Practices (cGMP)
โข Biotech Product Labeling, Advertising, and Promotion Regulations
โข Pharmacovigilance and Post-Marketing Surveillance in Biotech
โข Biotech Regulatory Strategy and Lifecycle Management
โข Interacting with Regulatory Authorities and preparing for FDA/EMA Inspections
โข Current Trends and Future Perspectives in Biotech Regulatory Affairs
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