Certificate in Biopharma Licensing: Essential Regulatory Insights
-- ViewingNowThe Certificate in Biopharma Licensing: Essential Regulatory Insights is a comprehensive course designed to empower learners with in-depth knowledge of the biopharmaceutical licensing process. This program highlights the importance of regulatory strategies, enabling you to understand the complex landscape of biopharma licensing.
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โข Introduction to Biopharma Licensing: Basics of biopharma licensing, types of licenses, and their importance.
โข Regulatory Landscape in Biopharma: Overview of global regulatory bodies, guidelines, and regulations.
โข Preclinical Research and Regulatory Requirements: Regulatory considerations for preclinical research, including GLP and GMP.
โข Clinical Trials and Regulatory Compliance: Phases of clinical trials, ICH-GCP, and IND submissions.
โข Biopharma Product Approval Process: NDA, BLA, and MAA submissions, and approval process.
โข Pharmacovigilance and Adverse Event Reporting: Monitoring, reporting, and managing adverse events.
โข Quality Assurance and Control in Biopharma Licensing: Importance of QA/QC in biopharma licensing and regulatory compliance.
โข Labeling, Packaging, and Distribution: Regulations related to labeling, packaging, and distribution of biopharma products.
โข Post-Marketing Surveillance and Compliance: Regulations and requirements for post-marketing surveillance and compliance.
โข Biopharma Licensing Challenges and Best Practices: Common challenges in biopharma licensing and best practices to overcome them.
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