Global Certificate in Healthcare Regulatory Affairs Fundamentals
-- ViewingNowThe Global Certificate in Healthcare Regulatory Affairs Fundamentals is a comprehensive course designed to empower learners with critical knowledge and skills in healthcare regulation. This certificate program highlights the importance of regulatory compliance in the healthcare industry, addressing the growing need for professionals who can navigate complex regulatory landscapes.
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โข Introduction to Healthcare Regulatory Affairs: Overview of the regulatory landscape, key players, and the importance of regulatory compliance in healthcare.
โข Global Regulatory Systems: Comparative analysis of major global regulatory systems, including the FDA, EMA, and others.
โข Medical Device Regulations: Understanding the regulations specific to medical devices, including classification, pre-market approval, and post-market surveillance.
โข Pharmaceutical Regulations: Exploring the regulations for pharmaceuticals, including clinical trials, marketing authorization, and pharmacovigilance.
โข Quality Management Systems: Overview of quality management systems, including ISO 13485 for medical devices and ISO 9001 for general quality management.
โข Regulatory Affairs in Clinical Trials: Understanding the regulatory requirements and processes for conducting clinical trials.
โข Labeling and Packaging Regulations: Overview of the regulations for labeling and packaging of medical devices and pharmaceuticals.
โข Regulatory Intelligence and Strategy: Introduction to regulatory intelligence, horizon scanning, and strategic planning in regulatory affairs.
โข Risk Management in Healthcare Regulatory Affairs: Understanding risk management principles and their application in regulatory affairs.
โข Regulatory Compliance and Inspections: Overview of regulatory compliance, audits, and inspections, including preparing for and managing inspections.
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