Professional Certificate in Drug Safety & Regulatory Compliance
-- ViewingNowThe Professional Certificate in Drug Safety & Regulatory Compliance is a crucial course designed to meet the growing industry demand for experts who can ensure compliance with drug safety regulations. This program equips learners with essential skills to navigate the complex landscape of pharmacovigilance and regulatory affairs.
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⢠Introduction to Drug Safety & Regulatory Compliance: Understanding the regulatory landscape, key players, and the importance of drug safety
⢠Pharmacovigilance: Monitoring, assessing, and understanding adverse drug reactions and patient safety
⢠Regulatory Affairs: Navigating the drug development process, regulatory submissions, and lifecycle management
⢠Good Clinical Practices (GCP): Ensuring ethical conduct and quality in clinical trials
⢠Good Laboratory Practices (GLP): Compliance and quality standards in preclinical research
⢠Good Manufacturing Practices (GMP): Quality assurance and control in drug manufacturing and distribution
⢠Risk Management: Identifying, assessing, and mitigating risks in drug development and post-market surveillance
⢠Quality Assurance & Quality Control: Ensuring consistent product quality and regulatory compliance
⢠Inspection Readiness: Preparing for and managing regulatory inspections and audits
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