Global Certificate in Healthcare Technology Regulations
-- ViewingNowThe Global Certificate in Healthcare Technology Regulations course is a comprehensive program designed to meet the growing industry demand for professionals with a deep understanding of regulatory frameworks in healthcare technology. This course emphasizes the importance of compliance, patient safety, and data security, making it essential for careers in this field.
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โข Global Healthcare Technology Regulations Overview: An introduction to global healthcare technology regulations, including primary stakeholders and the impact of regulations on healthcare technology companies. โข International Medical Device Regulations: An examination of regulations governing medical devices on a global scale, including European Union Medical Device Regulation (MDR), International Medical Device Regulators Forum (IMDRF), and International Organization for Standardization (ISO) standards. โข Healthcare Data Privacy and Security: A discussion of data privacy and security regulations, including the European Union General Data Protection Regulation (GDPR), Health Insurance Portability and Accountability Act (HIPAA), and California Consumer Privacy Act (CCPA). โข Global Pharmaceutical Regulations: A review of global pharmaceutical regulations, including the Food and Drug Administration (FDA) and the European Medicines Agency (EMA). โข Clinical Trials Regulations: An overview of clinical trials regulations, including International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) guidelines, and regional regulations such as the FDA and EMA. โข Health Technology Assessment (HTA): An exploration of HTA, including its role in healthcare technology regulation and evaluation, and its impact on market access. โข Digital Health Regulations: A review of digital health regulations, including telehealth, mobile health (mHealth), artificial intelligence (AI), and machine learning (ML). โข Regulatory Compliance Strategies: Best practices for regulatory compliance, including risk management, quality management, and lifecycle management.
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