Global Certificate in Biotech: Regulatory Considerations
-- ViewingNowThe Global Certificate in Biotech: Regulatory Considerations is a comprehensive course that provides learners with critical insights into the regulatory frameworks governing the biotechnology industry. This course highlights the importance of regulatory compliance in biotechnology, pharmaceuticals, and related fields, making it essential for professionals working in or seeking to enter these industries.
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โข Global Regulatory Landscape: Overview of global regulatory bodies and their roles in biotechnology, including FDA, EMA, and PMDA.
โข Regulatory Pathways: An in-depth look at regulatory pathways for biotech products, including premarket approval, clinical trials, and post-market surveillance.
โข Quality Systems: Understanding the importance of quality systems in biotech, including GxP, GLP, GMP, and GCP.
โข Regulatory Submissions: Best practices for creating and submitting regulatory documents, including IND, NDA, and BLA.
โข Regulatory Affairs Management: Strategies for managing regulatory affairs within a biotech organization, including resource allocation, communication, and compliance.
โข Pharmacovigilance: Monitoring and reporting adverse events, including safety surveillance, signal detection, and risk management.
โข Regulatory Intelligence: Keeping up-to-date with regulatory changes and trends, including horizon scanning, trend analysis, and regulatory impact assessment.
โข International Regulatory Cooperation: Understanding international regulatory cooperation and harmonization efforts, including ICH, PIC/S, and WHO.
โข Regulatory Strategy: Developing a comprehensive regulatory strategy, including target product profile, labeling, and lifecycle management.
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