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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⢠Introduction to Biotech Regulatory Affairs
⢠Global Regulatory Landscape for Biotech Products
⢠Regulatory Pathways for Biotech Drug Development
⢠Biotech Product Preclinical and Clinical Trials Regulation
⢠Quality Systems and Current Good Manufacturing Practices (cGMP)
⢠Biotech Product Labeling, Advertising, and Promotion Regulations
⢠Pharmacovigilance and Post-Marketing Surveillance in Biotech
⢠Biotech Regulatory Strategy and Lifecycle Management
⢠Interacting with Regulatory Authorities and preparing for FDA/EMA Inspections
⢠Current Trends and Future Perspectives in Biotech Regulatory Affairs
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