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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⢠Global Healthcare Technology Regulations Overview: An introduction to global healthcare technology regulations, including primary stakeholders and the impact of regulations on healthcare technology companies. ⢠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. ⢠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). ⢠Global Pharmaceutical Regulations: A review of global pharmaceutical regulations, including the Food and Drug Administration (FDA) and the European Medicines Agency (EMA). ⢠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. ⢠Health Technology Assessment (HTA): An exploration of HTA, including its role in healthcare technology regulation and evaluation, and its impact on market access. ⢠Digital Health Regulations: A review of digital health regulations, including telehealth, mobile health (mHealth), artificial intelligence (AI), and machine learning (ML). ⢠Regulatory Compliance Strategies: Best practices for regulatory compliance, including risk management, quality management, and lifecycle management.
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