Global Certificate in Biopharma Licensing: Regulatory Compliance
-- ViewingNowThe Global Certificate in Biopharma Licensing: Regulatory Compliance is a comprehensive course designed to meet the growing industry demand for professionals with expertise in biopharma licensing and regulatory affairs. This certificate course emphasizes the importance of regulatory compliance in the biopharma industry, empowering learners with essential skills to navigate the complex regulatory landscape.
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⢠Global Regulatory Landscape: Overview of global biopharma regulatory bodies and their compliance requirements.
⢠Clinical Trials Regulation: Compliance with ICH-GCP and other regional guidelines for clinical trials.
⢠Quality Assurance & Control: Implementing and maintaining QA/QC systems to ensure product quality and compliance.
⢠Pharmacovigilance & Pharmacoepidemiology: Monitoring drug safety, adverse event reporting, and pharmacoepidemiological studies.
⢠Regulatory Submissions & Approvals: Preparing and submitting regulatory applications for new drugs and biologics.
⢠Labeling & Packaging Compliance: Ensuring accurate and compliant labeling and packaging of biopharma products.
⢠Good Manufacturing Practices (GMP): Compliance with GMP regulations for biopharma manufacturing.
⢠Regulatory Inspections & Audits: Preparing for and managing regulatory inspections and audits.
⢠Post-Marketing Surveillance: Monitoring and reporting on the safety and efficacy of marketed biopharma products.
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